Fallopian Tube Clear Cell Adenocarcinoma, Fallopian Tube Endometrioid Adenocarcinoma, Fallopian Tube Mucinous Adenocarcinoma, Fallopian Tube Serous Adenocarcinoma, Fallopian Tube Transitional Cell Carcinoma, Fallopian Tube Undifferentiated Carcinoma, Ovarian Brenner Tumor, Ovarian Clear Cell Adenocarcinoma, Ovarian Endometrioid Adenocarcinoma, Ovarian Mucinous Adenocarcinoma, Ovarian Seromucinous Carcinoma, Ovarian Serous Adenocarcinoma, Ovarian Transitional Cell Carcinoma, Ovarian Undifferentiated Carcinoma, Primary Peritoneal Serous Adenocarcinoma, Stage IIIA Fallopian Tube Cancer AJCC v7, Stage IIIA Ovarian Cancer AJCC v6 and v7, Stage IIIA Primary Peritoneal Cancer AJCC v7, Stage IIIB Fallopian Tube Cancer AJCC v7, Stage IIIB Ovarian Cancer AJCC v6 and v7, Stage IIIB Primary Peritoneal Cancer AJCC v7, Stage IIIC Fallopian Tube Cancer AJCC v7, Stage IIIC Ovarian Cancer AJCC v6 and v7, Stage IIIC Primary Peritoneal Cancer AJCC v7, Stage IV Fallopian Tube Cancer AJCC v6 and v7, Stage IV Ovarian Cancer AJCC v6 and v7, Stage IV Primary Peritoneal Cancer AJCC v7
Conditions
Brief summary
This randomized phase III trial studies paclitaxel to see how well it works compared to polyglutamate paclitaxel or observation only in treating patients with stage III or stage IV ovarian epithelial, peritoneal cancer, or fallopian tube cancer. Drugs used in chemotherapy, such as paclitaxel and polyglutamate paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Paclitaxel and polyglutamate paclitaxel may also stop the growth of ovarian epithelial or peritoneal cancer by blocking blood flow to the tumor. Sometimes, after treatment, the tumor may not need additional treatment until it progresses. In this case, observation may be sufficient. It is not yet known whether paclitaxel is more effective than polyglutamate paclitaxel or observation only in treating ovarian epithelial, peritoneal, or fallopian tube cancer.
Detailed description
PRIMARY OBJECTIVES: I. To determine whether CT-2103 (polyglutamate paclitaxel) or paclitaxel, administered to women with advanced ovarian, primary peritoneal or fallopian tube cancer who have attained a clinically-defined complete response to primary platinum/taxane-based chemotherapy (consolidation/maintenance therapy) will reduce the death rate, compared to re-treatment at the time of documented disease progression. II. To determine if, in this clinical setting, CT-2103 produces a more favorable toxicity profile (with a particular focus on peripheral neuropathy as measured by the Gynecologic Oncology Group \[GOG\] NTX4) and superior quality-of-life (as measured by the Functional Assessment of Cancer Therapy-Ovarian \[FACT-O\]), compared to paclitaxel. SECONDARY OBJECTIVES: I. To explore the relationship between expression of several of the angiogenic markers and overall survival or progression-free survival in patients randomized to CT-2103, paclitaxel, or no treatment. II. To assess the association among the various tissue and serum markers of angiogenesis, and compare the ability of different combinations of these markers to predict patient outcome including overall survival and progression-free survival in patients randomized to CT-2103, paclitaxel, or no treatment. III. To bank deoxyribonucleic acid (DNA) from whole blood for research and evaluate the association between single nucleotide polymorphisms (SNPs) and measures of clinical outcome including overall survival, progression-free survival and adverse events. OUTLINE: Patients are randomized to 1 of 3 treatment arms. ARM I: Patients receive polyglutamate paclitaxel intravenously (IV) over 10-20 minutes on day 1. ARM II: Patients receive paclitaxel IV over 3 hours on day 1. ARM III: Patients receive no further anticancer treatment until evidence of disease progression. In arms I and II, treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 10 years.
Interventions
Undergo observation
Correlative studies
Given IV
Given IV
Ancillary studies
Sponsors
Study design
Eligibility
Inclusion criteria
* Patients with a histologic diagnosis of primary peritoneal carcinoma, or stage III or IV epithelial ovarian or fallopian tube carcinoma, with either optimal (=\< 1 cm residual disease) or suboptimal residual disease following initial surgery; all patients must have had appropriate surgery for ovarian, primary peritoneal or fallopian tube carcinoma with appropriate tissue available for histologic evaluation to confirm diagnosis and stage * Patients with the following histologic epithelial cell types are eligible: * Serous adenocarcinoma * Endometrioid adenocarcinoma * Mucinous adenocarcinoma * Undifferentiated carcinoma * Clear cell adenocarcinoma * Mixed epithelial carcinoma * Transitional cell carcinoma * Malignant Brenner tumor * Adenocarcinoma not otherwise specified (NOS) * Patients must have completed treatment within the past 12 weeks with at least 5 cycles and not more than 8 cycles of a platinum (IV or intraperitoneal \[IP\]) and paclitaxel or docetaxel-based combination chemotherapy and have no symptoms suggestive of persistent cancer, normal (no evidence of cancer) computed tomography (CT) scan of the abdomen/pelvis and normal cancer antigen 125 (CA-125) following this therapy * Patients treated with neo-adjuvant platinum-taxane chemotherapy for a presumptive diagnosis of stage III or IV epithelial ovarian, primary peritoneal or, fallopian tube (by paracentesis, percutaneous biopsy or open biopsy) are eligible provided that they have undergone interval abdominal surgery after at least one but no more than six cycles of standard chemotherapy; such surgery must meet the same criteria as for those undergoing up front surgery, including tissue diagnosis for confirmation of primary tumor site and stage III or IV disease; also, patients must have received at least two cycles after interval abdominal surgery * Absolute neutrophil count \>= 1,500/ul, equivalent to Common Toxicity Criteria (CTCAE version \[v\]3.0) grade 1 * Platelet count \>= 100,000/ul * Creatinine =\< 1.5 times institutional upper limit of normal (ULN), CTCAE v3.0 grade 1 * Bilirubin =\< 1.5 times ULN, (CTCAE v3.0 grade 1) * Serum glutamic oxaloacetic transaminase (SGOT) =\< 2.5 times ULN (CTCAE v3.0 grade 1) * Alkaline phosphatase =\< 2.5 times ULN (CTCAE v3.0 grade 1) * Neuropathy (sensory and motor) less than or equal to CTCAE v3.0 grade 1 * Gynecologic Oncology Group (GOG) performance status of 0, 1, or 2 * Patients must have signed an approved informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization * Patients must complete pre-entry assessments
Exclusion criteria
* Patients with a current diagnosis of epithelial ovarian or fallopian tube tumor of low malignant potential (LMP) (Borderline carcinomas) are not eligible; patients with a prior diagnosis of a low malignant potential tumor that was surgically resected and who subsequently develop invasive adenocarcinoma are eligible, provided that they have not received prior chemotherapy for their ovarian LMP tumor * Germ cell tumors, sex cord-stromal tumors, carcinosarcomas, mixed mullerian tumors or carcinosarcomas, metastatic carcinomas from other sites to the ovary and low malignant potential tumors including so called micropapillary serous carcinomas are not eligible * Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis are excluded; prior radiation for localized cancer of the breast, head and neck, or skin is permitted, provided that it was completed more than 3 years prior to registration, and the patient remains free of recurrent or metastatic disease * Patients who have received investigational therapies, and/or biological therapies (i.e. Bevacizumab or Erlotinib) for their epithelial ovarian, primary peritoneal or fallopian tube cancers or for any other abdominal or pelvic tumor, are not excluded; however, biologics cannot be continued concurrent with the GOG-012 maintenance treatment (or observation); patients who have received prior chemotherapy for any other abdominal or pelvic tumor (except as noted above) are excluded; patients may have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed more than 3 years prior to registration, and that the patient remains free of recurrent or metastatic disease * Patients with synchronous primary endometrial cancer, or a past history of primary endometrial cancer, are excluded, unless all of the following conditions are met: * Stage not greater than I-B * Less than 3 mm invasion without vascular or lymphatic invasion * No poorly differentiated subtypes, including papillary serous, clear cell, or other Federation of Gynecology and Obstetrics (FIGO) Grade 3 lesions * With the exception of non-melanoma skin cancer and other specific malignancies as noted above, patients with other invasive malignancies who had (or have) any evidence of the other cancer present within the last 5 years or whose previous cancer treatment contraindicates this protocol therapy are excluded * Patients with acute hepatitis, or known chronic hepatitis * Patients with an active infection that requires antibiotics * Patients with ongoing gastrointestinal bleeding requiring blood product support * Patients whose circumstances at the time of entry onto the protocol would not permit completion of study or required follow up * Patients with unstable angina or those who have had a myocardial infarction within the past six months; patients with evidence of abnormal cardiac conduction (e.g. bundle branch block, heart block) are eligible if their disease has been stable for the past six months * Patients are excluded who have had prior therapy with CT-2103 * Patients with active bleeding or an unexplained prothrombin time (PT) or partial thromboplastin time (PTT) \> institutional upper limit normal (ULN) * Patients who are pregnant or nursing are excluded; patients who may become pregnant must practice an effective method of birth control
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next five years. | Overall survival (OS) was defined as the number of months between study enrollment and death from any cause. Patients still alive at the last follow-up were censored on the date of last contact. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free Survival | Progression was assessed every 8 weeks for the first 15 months, then every 3 months, up to 14.2 years. | Progression free survival (PFS) was defined as the number of months between study enrollment and the date of first clinical, biochemical, or radiological evidence of progression or death due to any cause. Patients who were alive without progression at the time of analysis were censored on the date of the last tumor assessment. |
| Frequency and Severity of Adverse Effects Assessed by CTCAE v3.0 | Measured within 6 months of enrollment; through all cycles of chemotherapy and up to 30 days after the last cycle of chemotherapy. Up to 10 cycles of chemotherapy were allowed. Cycles were to be repeated every 3 weeks. | Number of treated patients with Adverse Events (grade 3 or higher) observed while receiving randomized therapy among adverse event terms with at least 4 patients reporting. |
| Patient-Reported Quality of Life (QOL) | 1. Prior to treatment 2. Prior to cycle 3 3. Prior to cycle 5 4. Prior to cycle 7 5. Prior to cycle 12 6. 12 months post treatment | Patient reported quality of life was measured with the Treatment Outcome Index (TOI) of the Functional Assessment of Cancer Therapy for ovarian cancer (FACT-O TOI). The FACT-En TOI is a scale for assessing general QOL of ovarian cancer patients. The FACT-O TOI score ranges 0-100 with a large score suggesting better QOL. |
| Patient-Reported Peripheral Neuropathy Symptoms | 1. Prior to treatment 2. Prior to cycle 3 3. Prior to cycle 5 4. Prior to cycle 7 5. Prior to cycle 12 6. 12 months post treatment | Patient reported peripheral neuropathy symptoms was measured with the Functional Assessment of Cancer Therapy/ Gynecologic Oncology Group - neurotoxicity subscale (short version) (FACT/GOG-Ntx subscale). The Ntx score ranges 0-16 with a large score suggesting less peripheral neuropathy symptoms. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Arm I (Paclitaxel Poliglumex) Patients receive polyglutamate paclitaxel IV over 10-20 minutes on day 1.Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Paclitaxel Poliglumex: Given IV
Quality-of-Life Assessment: Ancillary studies | 387 |
| Arm II (Paclitaxel) Patients receive paclitaxel IV over 3 hours on day 1. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Paclitaxel: Given IV
Quality-of-Life Assessment: Ancillary studies | 384 |
| Arm III (Observation) Patients receive no further anticancer treatment until evidence of disease progression.
Clinical Observation: Undergo observation
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies | 386 |
| Total | 1,157 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Ineligible | 7 | 13 | 13 |
| Overall Study | Never Treated | 8 | 10 | 12 |
| Overall Study | Withdrawal by Subject | 19 | 12 | 12 |
Baseline characteristics
| Characteristic | Arm II (Paclitaxel) | Arm III (Observation) | Arm I (Paclitaxel Poliglumex) | Total |
|---|---|---|---|---|
| Age, Continuous | 58.80 years STANDARD_DEVIATION 10.42 | 59.07 years STANDARD_DEVIATION 9.68 | 59.02 years STANDARD_DEVIATION 10.89 | 58.96 years STANDARD_DEVIATION 10.34 |
| Age, Customized 40 - 49 years | 71 Participants | 57 Participants | 54 Participants | 182 Participants |
| Age, Customized < 40 years | 13 Participants | 11 Participants | 21 Participants | 45 Participants |
| Age, Customized 50 - 59 years | 114 Participants | 138 Participants | 115 Participants | 367 Participants |
| Age, Customized 60 - 69 years | 132 Participants | 126 Participants | 137 Participants | 395 Participants |
| Age, Customized 70 - 79 years | 46 Participants | 49 Participants | 56 Participants | 151 Participants |
| Age, Customized >= 80 years | 8 Participants | 5 Participants | 4 Participants | 17 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 25 Participants | 16 Participants | 18 Participants | 59 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 338 Participants | 346 Participants | 341 Participants | 1025 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 21 Participants | 24 Participants | 28 Participants | 73 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants | 1 Participants | 1 Participants | 5 Participants |
| Race (NIH/OMB) Asian | 11 Participants | 9 Participants | 7 Participants | 27 Participants |
| Race (NIH/OMB) Black or African American | 13 Participants | 17 Participants | 21 Participants | 51 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 3 Participants | 4 Participants | 11 Participants |
| Race (NIH/OMB) White | 352 Participants | 355 Participants | 353 Participants | 1060 Participants |
| Sex: Female, Male Female | 384 Participants | 386 Participants | 387 Participants | 1157 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 235 / 387 | 242 / 384 | 230 / 386 |
| other Total, other adverse events | 378 / 379 | 372 / 374 | 312 / 386 |
| serious Total, serious adverse events | 50 / 379 | 39 / 374 | 1 / 386 |
Outcome results
Overall Survival
Overall survival (OS) was defined as the number of months between study enrollment and death from any cause. Patients still alive at the last follow-up were censored on the date of last contact.
Time frame: All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next five years.
Population: All randomized
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arm I (Paclitaxel Poliglumex) | Overall Survival | 60.0 Months |
| Arm II (Paclitaxel) | Overall Survival | 56.8 Months |
| Arm III (Observation) | Overall Survival | 58.3 Months |
Frequency and Severity of Adverse Effects Assessed by CTCAE v3.0
Number of treated patients with Adverse Events (grade 3 or higher) observed while receiving randomized therapy among adverse event terms with at least 4 patients reporting.
Time frame: Measured within 6 months of enrollment; through all cycles of chemotherapy and up to 30 days after the last cycle of chemotherapy. Up to 10 cycles of chemotherapy were allowed. Cycles were to be repeated every 3 weeks.
Population: Treated with randomized therapy
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm I (Paclitaxel Poliglumex) | Frequency and Severity of Adverse Effects Assessed by CTCAE v3.0 | Hypertension | 2 participants |
| Arm I (Paclitaxel Poliglumex) | Frequency and Severity of Adverse Effects Assessed by CTCAE v3.0 | Allergic Reaction / Hypersensitivity | 4 participants |
| Arm I (Paclitaxel Poliglumex) | Frequency and Severity of Adverse Effects Assessed by CTCAE v3.0 | Pain: Abdominal Pain Nos | 12 participants |
| Arm I (Paclitaxel Poliglumex) | Frequency and Severity of Adverse Effects Assessed by CTCAE v3.0 | Hypokalemia | 9 participants |
| Arm I (Paclitaxel Poliglumex) | Frequency and Severity of Adverse Effects Assessed by CTCAE v3.0 | Dyspnea | 2 participants |
| Arm I (Paclitaxel Poliglumex) | Frequency and Severity of Adverse Effects Assessed by CTCAE v3.0 | Obstruction, GI - Small Bowel Nos | 5 participants |
| Arm I (Paclitaxel Poliglumex) | Frequency and Severity of Adverse Effects Assessed by CTCAE v3.0 | Leukocytes | 36 participants |
| Arm I (Paclitaxel Poliglumex) | Frequency and Severity of Adverse Effects Assessed by CTCAE v3.0 | Vomiting | 8 participants |
| Arm I (Paclitaxel Poliglumex) | Frequency and Severity of Adverse Effects Assessed by CTCAE v3.0 | Neutrophils | 82 participants |
| Arm I (Paclitaxel Poliglumex) | Frequency and Severity of Adverse Effects Assessed by CTCAE v3.0 | Nausea | 7 participants |
| Arm I (Paclitaxel Poliglumex) | Frequency and Severity of Adverse Effects Assessed by CTCAE v3.0 | Pain: Joint | 5 participants |
| Arm I (Paclitaxel Poliglumex) | Frequency and Severity of Adverse Effects Assessed by CTCAE v3.0 | Neuropathy-Motor | 3 participants |
| Arm I (Paclitaxel Poliglumex) | Frequency and Severity of Adverse Effects Assessed by CTCAE v3.0 | Fatigue | 6 participants |
| Arm I (Paclitaxel Poliglumex) | Frequency and Severity of Adverse Effects Assessed by CTCAE v3.0 | Thrombosis / Thrombus / Embolism | 5 participants |
| Arm I (Paclitaxel Poliglumex) | Frequency and Severity of Adverse Effects Assessed by CTCAE v3.0 | Pain: Head/Headache | 4 participants |
| Arm I (Paclitaxel Poliglumex) | Frequency and Severity of Adverse Effects Assessed by CTCAE v3.0 | Hemoglobin | 8 participants |
| Arm I (Paclitaxel Poliglumex) | Frequency and Severity of Adverse Effects Assessed by CTCAE v3.0 | Diarrhea | 7 participants |
| Arm I (Paclitaxel Poliglumex) | Frequency and Severity of Adverse Effects Assessed by CTCAE v3.0 | Pain: Extremity-Limb | 1 participants |
| Arm I (Paclitaxel Poliglumex) | Frequency and Severity of Adverse Effects Assessed by CTCAE v3.0 | Hyperglycemia | 5 participants |
| Arm I (Paclitaxel Poliglumex) | Frequency and Severity of Adverse Effects Assessed by CTCAE v3.0 | Dehydration | 4 participants |
| Arm I (Paclitaxel Poliglumex) | Frequency and Severity of Adverse Effects Assessed by CTCAE v3.0 | Pain: Back | 7 participants |
| Arm II (Paclitaxel) | Frequency and Severity of Adverse Effects Assessed by CTCAE v3.0 | Pain: Joint | 3 participants |
| Arm II (Paclitaxel) | Frequency and Severity of Adverse Effects Assessed by CTCAE v3.0 | Allergic Reaction / Hypersensitivity | 0 participants |
| Arm II (Paclitaxel) | Frequency and Severity of Adverse Effects Assessed by CTCAE v3.0 | Dehydration | 1 participants |
| Arm II (Paclitaxel) | Frequency and Severity of Adverse Effects Assessed by CTCAE v3.0 | Diarrhea | 3 participants |
| Arm II (Paclitaxel) | Frequency and Severity of Adverse Effects Assessed by CTCAE v3.0 | Dyspnea | 4 participants |
| Arm II (Paclitaxel) | Frequency and Severity of Adverse Effects Assessed by CTCAE v3.0 | Fatigue | 13 participants |
| Arm II (Paclitaxel) | Frequency and Severity of Adverse Effects Assessed by CTCAE v3.0 | Hemoglobin | 2 participants |
| Arm II (Paclitaxel) | Frequency and Severity of Adverse Effects Assessed by CTCAE v3.0 | Hyperglycemia | 6 participants |
| Arm II (Paclitaxel) | Frequency and Severity of Adverse Effects Assessed by CTCAE v3.0 | Hypertension | 4 participants |
| Arm II (Paclitaxel) | Frequency and Severity of Adverse Effects Assessed by CTCAE v3.0 | Hypokalemia | 2 participants |
| Arm II (Paclitaxel) | Frequency and Severity of Adverse Effects Assessed by CTCAE v3.0 | Leukocytes | 17 participants |
| Arm II (Paclitaxel) | Frequency and Severity of Adverse Effects Assessed by CTCAE v3.0 | Nausea | 3 participants |
| Arm II (Paclitaxel) | Frequency and Severity of Adverse Effects Assessed by CTCAE v3.0 | Neuropathy-Motor | 8 participants |
| Arm II (Paclitaxel) | Frequency and Severity of Adverse Effects Assessed by CTCAE v3.0 | Neutrophils | 62 participants |
| Arm II (Paclitaxel) | Frequency and Severity of Adverse Effects Assessed by CTCAE v3.0 | Obstruction, GI - Small Bowel Nos | 6 participants |
| Arm II (Paclitaxel) | Frequency and Severity of Adverse Effects Assessed by CTCAE v3.0 | Pain: Abdominal Pain Nos | 5 participants |
| Arm II (Paclitaxel) | Frequency and Severity of Adverse Effects Assessed by CTCAE v3.0 | Pain: Back | 4 participants |
| Arm II (Paclitaxel) | Frequency and Severity of Adverse Effects Assessed by CTCAE v3.0 | Pain: Extremity-Limb | 7 participants |
| Arm II (Paclitaxel) | Frequency and Severity of Adverse Effects Assessed by CTCAE v3.0 | Pain: Head/Headache | 2 participants |
| Arm II (Paclitaxel) | Frequency and Severity of Adverse Effects Assessed by CTCAE v3.0 | Thrombosis / Thrombus / Embolism | 4 participants |
| Arm II (Paclitaxel) | Frequency and Severity of Adverse Effects Assessed by CTCAE v3.0 | Vomiting | 6 participants |
| Arm III (Observation) | Frequency and Severity of Adverse Effects Assessed by CTCAE v3.0 | Hypertension | 5 participants |
| Arm III (Observation) | Frequency and Severity of Adverse Effects Assessed by CTCAE v3.0 | Dehydration | 1 participants |
| Arm III (Observation) | Frequency and Severity of Adverse Effects Assessed by CTCAE v3.0 | Pain: Abdominal Pain Nos | 5 participants |
| Arm III (Observation) | Frequency and Severity of Adverse Effects Assessed by CTCAE v3.0 | Hyperglycemia | 1 participants |
| Arm III (Observation) | Frequency and Severity of Adverse Effects Assessed by CTCAE v3.0 | Vomiting | 3 participants |
| Arm III (Observation) | Frequency and Severity of Adverse Effects Assessed by CTCAE v3.0 | Pain: Back | 1 participants |
| Arm III (Observation) | Frequency and Severity of Adverse Effects Assessed by CTCAE v3.0 | Hemoglobin | 0 participants |
| Arm III (Observation) | Frequency and Severity of Adverse Effects Assessed by CTCAE v3.0 | Thrombosis / Thrombus / Embolism | 2 participants |
| Arm III (Observation) | Frequency and Severity of Adverse Effects Assessed by CTCAE v3.0 | Pain: Extremity-Limb | 0 participants |
| Arm III (Observation) | Frequency and Severity of Adverse Effects Assessed by CTCAE v3.0 | Fatigue | 1 participants |
| Arm III (Observation) | Frequency and Severity of Adverse Effects Assessed by CTCAE v3.0 | Allergic Reaction / Hypersensitivity | 0 participants |
| Arm III (Observation) | Frequency and Severity of Adverse Effects Assessed by CTCAE v3.0 | Pain: Head/Headache | 0 participants |
| Arm III (Observation) | Frequency and Severity of Adverse Effects Assessed by CTCAE v3.0 | Nausea | 4 participants |
| Arm III (Observation) | Frequency and Severity of Adverse Effects Assessed by CTCAE v3.0 | Dyspnea | 2 participants |
| Arm III (Observation) | Frequency and Severity of Adverse Effects Assessed by CTCAE v3.0 | Neuropathy-Motor | 1 participants |
| Arm III (Observation) | Frequency and Severity of Adverse Effects Assessed by CTCAE v3.0 | Leukocytes | 1 participants |
| Arm III (Observation) | Frequency and Severity of Adverse Effects Assessed by CTCAE v3.0 | Diarrhea | 2 participants |
| Arm III (Observation) | Frequency and Severity of Adverse Effects Assessed by CTCAE v3.0 | Neutrophils | 2 participants |
| Arm III (Observation) | Frequency and Severity of Adverse Effects Assessed by CTCAE v3.0 | Hypokalemia | 0 participants |
| Arm III (Observation) | Frequency and Severity of Adverse Effects Assessed by CTCAE v3.0 | Pain: Joint | 1 participants |
| Arm III (Observation) | Frequency and Severity of Adverse Effects Assessed by CTCAE v3.0 | Obstruction, GI - Small Bowel Nos | 9 participants |
Patient-Reported Peripheral Neuropathy Symptoms
Patient reported peripheral neuropathy symptoms was measured with the Functional Assessment of Cancer Therapy/ Gynecologic Oncology Group - neurotoxicity subscale (short version) (FACT/GOG-Ntx subscale). The Ntx score ranges 0-16 with a large score suggesting less peripheral neuropathy symptoms.
Time frame: 1. Prior to treatment 2. Prior to cycle 3 3. Prior to cycle 5 4. Prior to cycle 7 5. Prior to cycle 12 6. 12 months post treatment
Population: Provided baseline and \>= 1 follow-up assessment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm I (Paclitaxel Poliglumex) | Patient-Reported Peripheral Neuropathy Symptoms | Baseline | 11.4 score on a scale | Standard Error 0.2 |
| Arm I (Paclitaxel Poliglumex) | Patient-Reported Peripheral Neuropathy Symptoms | Prior to cycle 3 | 9.6 score on a scale | Standard Error 0.2 |
| Arm I (Paclitaxel Poliglumex) | Patient-Reported Peripheral Neuropathy Symptoms | Prior to cycle 5 | 9.5 score on a scale | Standard Error 0.2 |
| Arm I (Paclitaxel Poliglumex) | Patient-Reported Peripheral Neuropathy Symptoms | Prior to cycle 7 | 9.8 score on a scale | Standard Error 0.2 |
| Arm I (Paclitaxel Poliglumex) | Patient-Reported Peripheral Neuropathy Symptoms | Prior to cycle 12 | 9.4 score on a scale | Standard Error 0.2 |
| Arm I (Paclitaxel Poliglumex) | Patient-Reported Peripheral Neuropathy Symptoms | 12 months post treatment | 10.7 score on a scale | Standard Error 0.3 |
| Arm II (Paclitaxel) | Patient-Reported Peripheral Neuropathy Symptoms | 12 months post treatment | 11.7 score on a scale | Standard Error 0.3 |
| Arm II (Paclitaxel) | Patient-Reported Peripheral Neuropathy Symptoms | Baseline | 11.7 score on a scale | Standard Error 0.2 |
| Arm II (Paclitaxel) | Patient-Reported Peripheral Neuropathy Symptoms | Prior to cycle 7 | 11.3 score on a scale | Standard Error 0.2 |
| Arm II (Paclitaxel) | Patient-Reported Peripheral Neuropathy Symptoms | Prior to cycle 12 | 11.6 score on a scale | Standard Error 0.2 |
| Arm II (Paclitaxel) | Patient-Reported Peripheral Neuropathy Symptoms | Prior to cycle 3 | 10.6 score on a scale | Standard Error 0.2 |
| Arm II (Paclitaxel) | Patient-Reported Peripheral Neuropathy Symptoms | Prior to cycle 5 | 11.3 score on a scale | Standard Error 0.2 |
| Arm III (Observation) | Patient-Reported Peripheral Neuropathy Symptoms | Prior to cycle 3 | 11.5 score on a scale | Standard Error 0.2 |
| Arm III (Observation) | Patient-Reported Peripheral Neuropathy Symptoms | Prior to cycle 5 | 11.9 score on a scale | Standard Error 0.2 |
| Arm III (Observation) | Patient-Reported Peripheral Neuropathy Symptoms | 12 months post treatment | 12.4 score on a scale | Standard Error 0.2 |
| Arm III (Observation) | Patient-Reported Peripheral Neuropathy Symptoms | Prior to cycle 7 | 12.4 score on a scale | Standard Error 0.2 |
| Arm III (Observation) | Patient-Reported Peripheral Neuropathy Symptoms | Baseline | 11.8 score on a scale | Standard Error 0.2 |
| Arm III (Observation) | Patient-Reported Peripheral Neuropathy Symptoms | Prior to cycle 12 | 12.2 score on a scale | Standard Error 0.2 |
Patient-Reported Quality of Life (QOL)
Patient reported quality of life was measured with the Treatment Outcome Index (TOI) of the Functional Assessment of Cancer Therapy for ovarian cancer (FACT-O TOI). The FACT-En TOI is a scale for assessing general QOL of ovarian cancer patients. The FACT-O TOI score ranges 0-100 with a large score suggesting better QOL.
Time frame: 1. Prior to treatment 2. Prior to cycle 3 3. Prior to cycle 5 4. Prior to cycle 7 5. Prior to cycle 12 6. 12 months post treatment
Population: Provided baseline and \>= 1 follow-up assessment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm I (Paclitaxel Poliglumex) | Patient-Reported Quality of Life (QOL) | Baseline | 78.2 score on a scale | Standard Error 0.6 |
| Arm I (Paclitaxel Poliglumex) | Patient-Reported Quality of Life (QOL) | Prior to cycle 3 | 78.8 score on a scale | Standard Error 0.7 |
| Arm I (Paclitaxel Poliglumex) | Patient-Reported Quality of Life (QOL) | Prior to cycle 5 | 79.3 score on a scale | Standard Error 0.7 |
| Arm I (Paclitaxel Poliglumex) | Patient-Reported Quality of Life (QOL) | Prior to cycle 7 | 80.0 score on a scale | Standard Error 0.7 |
| Arm I (Paclitaxel Poliglumex) | Patient-Reported Quality of Life (QOL) | Prior to cycle 12 | 78.3 score on a scale | Standard Error 0.8 |
| Arm I (Paclitaxel Poliglumex) | Patient-Reported Quality of Life (QOL) | 12 months post treatment | 78.8 score on a scale | Standard Error 0.9 |
| Arm II (Paclitaxel) | Patient-Reported Quality of Life (QOL) | 12 months post treatment | 76.0 score on a scale | Standard Error 0.9 |
| Arm II (Paclitaxel) | Patient-Reported Quality of Life (QOL) | Baseline | 77.3 score on a scale | Standard Error 0.7 |
| Arm II (Paclitaxel) | Patient-Reported Quality of Life (QOL) | Prior to cycle 7 | 77.5 score on a scale | Standard Error 0.8 |
| Arm II (Paclitaxel) | Patient-Reported Quality of Life (QOL) | Prior to cycle 12 | 76.8 score on a scale | Standard Error 0.8 |
| Arm II (Paclitaxel) | Patient-Reported Quality of Life (QOL) | Prior to cycle 3 | 76.9 score on a scale | Standard Error 0.7 |
| Arm II (Paclitaxel) | Patient-Reported Quality of Life (QOL) | Prior to cycle 5 | 77.6 score on a scale | Standard Error 0.7 |
| Arm III (Observation) | Patient-Reported Quality of Life (QOL) | Prior to cycle 3 | 80.0 score on a scale | Standard Error 0.7 |
| Arm III (Observation) | Patient-Reported Quality of Life (QOL) | Prior to cycle 5 | 80.8 score on a scale | Standard Error 0.7 |
| Arm III (Observation) | Patient-Reported Quality of Life (QOL) | 12 months post treatment | 77.4 score on a scale | Standard Error 0.9 |
| Arm III (Observation) | Patient-Reported Quality of Life (QOL) | Prior to cycle 7 | 79.5 score on a scale | Standard Error 0.8 |
| Arm III (Observation) | Patient-Reported Quality of Life (QOL) | Baseline | 77.4 score on a scale | Standard Error 0.7 |
| Arm III (Observation) | Patient-Reported Quality of Life (QOL) | Prior to cycle 12 | 79.2 score on a scale | Standard Error 0.8 |
Progression-free Survival
Progression free survival (PFS) was defined as the number of months between study enrollment and the date of first clinical, biochemical, or radiological evidence of progression or death due to any cause. Patients who were alive without progression at the time of analysis were censored on the date of the last tumor assessment.
Time frame: Progression was assessed every 8 weeks for the first 15 months, then every 3 months, up to 14.2 years.
Population: All randomized
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arm I (Paclitaxel Poliglumex) | Progression-free Survival | 16.3 Months |
| Arm II (Paclitaxel) | Progression-free Survival | 18.9 Months |
| Arm III (Observation) | Progression-free Survival | 13.4 Months |