Fallopian Tube Carcinoma, Primary Peritoneal Carcinoma, Recurrent Ovarian Carcinoma
Conditions
Brief summary
This phase II trial is studying the side effects and how well paclitaxel albumin-stabilized nanoparticle formulation works in treating patients with recurrent or persistent ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer. Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
Detailed description
PRIMARY OBJECTIVES: I. Determine the antitumor activity of paclitaxel albumin-stabilized nanoparticle formulation (Abraxane®), in terms of frequency and duration of objective response, in patients with persistent or recurrent platinum-resistant ovarian epithelial, fallopian tube, or primary peritoneal cancer. II. Determine the toxicity of this drug in these patients. SECONDARY OBJECTIVES: I. Determine the duration of progression-free survival and overall survival of patients treated with this drug. OUTLINE: This is a multicenter study. Patients receive paclitaxel albumin-stabilized nanoparticle formulation (Abraxane®) IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days 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 3 years.
Interventions
DRUGPaclitaxel Albumin-Stabilized Nanoparticle Formulation
Sponsors
National Cancer Institute (NCI)
Gynecologic Oncology Group
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
* Histologically confirmed diagnosis of 1 of the following: * Ovarian epithelial cancer * Fallopian tube cancer * Primary peritoneal carcinoma * Recurrent or persistent disease * Must have received 1 prior platinum-based chemotherapy regimen containing carboplatin, cisplatin, or another organoplatinum compound for management of primary disease * Initial treatment may have included intraperitoneal therapy, high-dose therapy, consolidation therapy, or extended therapy administered after a surgical or nonsurgical assessment * Patients who have not received prior paclitaxel-based chemotherapy must receive a second regimen that includes paclitaxel or docetaxel * Platinum-resistant or refractory disease, defined by 1 of the following: * Treatment-free interval of \< 6 months after completion of platinum-based therapy * Persistent disease at completion of primary platinum-based therapy * Progressive disease during platinum-based therapy * Paclitaxel-resistant disease, defined as having had a treatment-free interval \< 6 months or shown disease progression during paclitaxel-based therapy * Patients who have not received prior paclitaxel-based chemotherapy must receive a second regimen that includes paclitaxel or docetaxel * Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan * Must have ≥ 1 target lesion that can be used to assess response * Tumors within a previously irradiated field are designated as non-target lesions unless progression is documented or biopsy confirms persistence ≥ 90 days after completion of radiotherapy * Not a candidate for a higher priority GOG protocol * GOG performance status 0-2 * ANC ≥ 1,500/mm³ * Platelet count ≥ 100,000/mm³ * Hemoglobin ≥ 9.0 g/dL * Creatinine ≤ 1.5 times upper limit of normal (ULN) * Bilirubin normal * SGOT ≤ 2.5 times ULN * Alkaline phosphatase ≤ 2.5 times ULN * No active infection requiring antibiotics * No sensory or motor neuropathy \> grade 1 * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * PT INR ≤ 1.5 or in-range INR 2-3 (if patient is on a stable dose of therapeutic warfarin) * PTT \< 1.2 times control * No concurrent serious medical or psychiatric illness, including serious active infection * No uncontrolled hypertension (i.e., blood pressure ≥ 150/100 mm Hg) * No uncompensated congestive heart failure or symptomatic coronary artery disease * No myocardial infarction within the past 6 months * No active bleeding * No other invasive malignancies within the past 5 years except for nonmelanoma skin cancer * No history of allergic reactions attributed to chemical or biological composition to paclitaxel or other study agents * No concurrent amifostine or other protective reagents * Recovered from prior surgery, radiotherapy, or chemotherapy * No prior paclitaxel albumin-stabilized nanoparticle formulation (Abraxane®) * No prior cancer treatment that would preclude study therapy * No additional prior cytotoxic chemotherapy for management of recurrent or persistent disease, including retreatment with initial chemotherapy regimens * One additional prior noncytotoxic regimen (i.e., monoclonal antibodies, cytokines, or small molecule inhibitors of signal transduction) for management of recurrent or persistent disease allowed * At least 1 week since prior hormonal therapy directed at the malignant tumor * Concurrent hormone replacement therapy allowed * At least 3 weeks since other prior therapy directed at the malignant tumor, including biologic therapy, immunologic agents, or radiotherapy * More than 5 years since prior chemotherapy for any other portion of the abdominal cavity or pelvis, unless for treatment of ovarian, primary peritoneal, or fallopian tube cancer * Prior adjuvant chemotherapy for localized breast cancer allowed provided it was completed \> 3 years ago and patient remains free of recurrent or metastatic disease * More than 5 years since prior radiotherapy to any other portion of the abdominal cavity or pelvis, unless for treatment of ovarian, primary peritoneal, or fallopian tube cancer * Prior radiotherapy for localized breast cancer, cancer of the head and neck, or skin cancer allowed provided it was completed \> 3 years ago and patient remains free of recurrent or metastatic disease * No prior radiotherapy to \> 25% of marrow-bearing areas
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tumor Response | every other cycle for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels | Complete and Partial Tumor Response by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0). Per RECIST v1.0 for target lesions and assessed by MRIor CT scan: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. CT scan or MRI if used to follow lesion for measurable disease every other cycle for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels. Responses must be confirmed by repeat imaging 4 weeks following documentation of response. |
| Frequency and Severity of Observed Adverse Effects | Every cycle during treatment and up to 5 years after completion of treatment | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free Survival | from study entry until disease progression, death or date of last contact. | Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since study entry, or unequivocal progression of existing non-target lesions, or the appearance of one or more new lesions. CT scan or MRI if used to follow lesion for measurable disease every other cycle for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels. Responses must be confirmed by repeat imaging 4 weeks following documentation of response. |
| Overall Survival | from entry into the study to death or the date of last contact. | — |
Countries
United States
Participant flow
Recruitment details
The study was activated on 6/4/2007 and closed to accrual on 1/29/2009.
Participants by arm
| Arm | Count |
|---|---|
| Abraxane® Abraxane® 100 mg/m2 infused I.V. over 30 minutes weekly on days 1, 8, and 15 every 28 days until disease progression or adverse effects prohibit further therapy. | 47 |
| Total | 47 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 3 |
| Overall Study | Ineligible | 4 |
| Overall Study | <no further label> | 3 |
| Overall Study | Refused further treatment | 2 |
Baseline characteristics
| Characteristic | Abraxane® |
|---|---|
| Age, Customized 20-29 years | 0 participants |
| Age, Customized 30-39 years | 1 participants |
| Age, Customized 40-49 years | 8 participants |
| Age, Customized 50-59 years | 16 participants |
| Age, Customized 60-69 years | 15 participants |
| Age, Customized 70-79 years | 7 participants |
| Sex: Female, Male Female | 47 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 47 / 47 |
| serious Total, serious adverse events | 11 / 47 |
Outcome results
Primary
Frequency and Severity of Observed Adverse Effects
Time frame: Every cycle during treatment and up to 5 years after completion of treatment
Population: Treated and Eligible patients
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Abraxane® | Frequency and Severity of Observed Adverse Effects | Dermatologic | 28 Participants |
| Abraxane® | Frequency and Severity of Observed Adverse Effects | Other neurological | 42 Participants |
| Abraxane® | Frequency and Severity of Observed Adverse Effects | Neutropenia | 30 Participants |
| Abraxane® | Frequency and Severity of Observed Adverse Effects | Musculoskeletal | 44 Participants |
| Abraxane® | Frequency and Severity of Observed Adverse Effects | Ocular/Visual | 45 Participants |
| Abraxane® | Frequency and Severity of Observed Adverse Effects | Thrombocytopenia | 43 Participants |
| Abraxane® | Frequency and Severity of Observed Adverse Effects | Anemia | 5 Participants |
| Abraxane® | Frequency and Severity of Observed Adverse Effects | Pain | 32 Participants |
| Abraxane® | Frequency and Severity of Observed Adverse Effects | Constitutional | 12 Participants |
| Abraxane® | Frequency and Severity of Observed Adverse Effects | Cardiac | 45 Participants |
| Abraxane® | Frequency and Severity of Observed Adverse Effects | Metabolic | 35 Participants |
| Abraxane® | Frequency and Severity of Observed Adverse Effects | Hemorrhage | 45 Participants |
| Abraxane® | Frequency and Severity of Observed Adverse Effects | Leukopenia | 20 Participants |
| Abraxane® | Frequency and Severity of Observed Adverse Effects | Pulmonary | 40 Participants |
| Abraxane® | Frequency and Severity of Observed Adverse Effects | Lymphatics | 41 Participants |
| Abraxane® | Frequency and Severity of Observed Adverse Effects | Gastrointestinal | 18 Participants |
| Abraxane® | Frequency and Severity of Observed Adverse Effects | Neurosensory | 27 Participants |
| Grade 1 (CTCAE v 3.0) | Frequency and Severity of Observed Adverse Effects | Thrombocytopenia | 4 Participants |
| Grade 1 (CTCAE v 3.0) | Frequency and Severity of Observed Adverse Effects | Musculoskeletal | 2 Participants |
| Grade 1 (CTCAE v 3.0) | Frequency and Severity of Observed Adverse Effects | Neurosensory | 14 Participants |
| Grade 1 (CTCAE v 3.0) | Frequency and Severity of Observed Adverse Effects | Ocular/Visual | 1 Participants |
| Grade 1 (CTCAE v 3.0) | Frequency and Severity of Observed Adverse Effects | Pain | 10 Participants |
| Grade 1 (CTCAE v 3.0) | Frequency and Severity of Observed Adverse Effects | Metabolic | 8 Participants |
| Grade 1 (CTCAE v 3.0) | Frequency and Severity of Observed Adverse Effects | Pulmonary | 3 Participants |
| Grade 1 (CTCAE v 3.0) | Frequency and Severity of Observed Adverse Effects | Neutropenia | 5 Participants |
| Grade 1 (CTCAE v 3.0) | Frequency and Severity of Observed Adverse Effects | Other neurological | 4 Participants |
| Grade 1 (CTCAE v 3.0) | Frequency and Severity of Observed Adverse Effects | Anemia | 19 Participants |
| Grade 1 (CTCAE v 3.0) | Frequency and Severity of Observed Adverse Effects | Cardiac | 2 Participants |
| Grade 1 (CTCAE v 3.0) | Frequency and Severity of Observed Adverse Effects | Constitutional | 20 Participants |
| Grade 1 (CTCAE v 3.0) | Frequency and Severity of Observed Adverse Effects | Dermatologic | 10 Participants |
| Grade 1 (CTCAE v 3.0) | Frequency and Severity of Observed Adverse Effects | Gastrointestinal | 19 Participants |
| Grade 1 (CTCAE v 3.0) | Frequency and Severity of Observed Adverse Effects | Hemorrhage | 1 Participants |
| Grade 1 (CTCAE v 3.0) | Frequency and Severity of Observed Adverse Effects | Lymphatics | 6 Participants |
| Grade 1 (CTCAE v 3.0) | Frequency and Severity of Observed Adverse Effects | Leukopenia | 15 Participants |
| Grade 2 (CTCAE v 3.0) | Frequency and Severity of Observed Adverse Effects | Neutropenia | 6 Participants |
| Grade 2 (CTCAE v 3.0) | Frequency and Severity of Observed Adverse Effects | Thrombocytopenia | 0 Participants |
| Grade 2 (CTCAE v 3.0) | Frequency and Severity of Observed Adverse Effects | Leukopenia | 11 Participants |
| Grade 2 (CTCAE v 3.0) | Frequency and Severity of Observed Adverse Effects | Dermatologic | 9 Participants |
| Grade 2 (CTCAE v 3.0) | Frequency and Severity of Observed Adverse Effects | Ocular/Visual | 1 Participants |
| Grade 2 (CTCAE v 3.0) | Frequency and Severity of Observed Adverse Effects | Pulmonary | 4 Participants |
| Grade 2 (CTCAE v 3.0) | Frequency and Severity of Observed Adverse Effects | Metabolic | 2 Participants |
| Grade 2 (CTCAE v 3.0) | Frequency and Severity of Observed Adverse Effects | Gastrointestinal | 8 Participants |
| Grade 2 (CTCAE v 3.0) | Frequency and Severity of Observed Adverse Effects | Pain | 3 Participants |
| Grade 2 (CTCAE v 3.0) | Frequency and Severity of Observed Adverse Effects | Lymphatics | 0 Participants |
| Grade 2 (CTCAE v 3.0) | Frequency and Severity of Observed Adverse Effects | Other neurological | 1 Participants |
| Grade 2 (CTCAE v 3.0) | Frequency and Severity of Observed Adverse Effects | Hemorrhage | 1 Participants |
| Grade 2 (CTCAE v 3.0) | Frequency and Severity of Observed Adverse Effects | Cardiac | 0 Participants |
| Grade 2 (CTCAE v 3.0) | Frequency and Severity of Observed Adverse Effects | Neurosensory | 5 Participants |
| Grade 2 (CTCAE v 3.0) | Frequency and Severity of Observed Adverse Effects | Anemia | 20 Participants |
| Grade 2 (CTCAE v 3.0) | Frequency and Severity of Observed Adverse Effects | Musculoskeletal | 1 Participants |
| Grade 2 (CTCAE v 3.0) | Frequency and Severity of Observed Adverse Effects | Constitutional | 15 Participants |
| Grade 3 (CTCAE v 3.0) | Frequency and Severity of Observed Adverse Effects | Pulmonary | 0 Participants |
| Grade 3 (CTCAE v 3.0) | Frequency and Severity of Observed Adverse Effects | Neurosensory | 1 Participants |
| Grade 3 (CTCAE v 3.0) | Frequency and Severity of Observed Adverse Effects | Other neurological | 0 Participants |
| Grade 3 (CTCAE v 3.0) | Frequency and Severity of Observed Adverse Effects | Leukopenia | 1 Participants |
| Grade 3 (CTCAE v 3.0) | Frequency and Severity of Observed Adverse Effects | Thrombocytopenia | 0 Participants |
| Grade 3 (CTCAE v 3.0) | Frequency and Severity of Observed Adverse Effects | Neutropenia | 6 Participants |
| Grade 3 (CTCAE v 3.0) | Frequency and Severity of Observed Adverse Effects | Anemia | 3 Participants |
| Grade 3 (CTCAE v 3.0) | Frequency and Severity of Observed Adverse Effects | Cardiac | 0 Participants |
| Grade 3 (CTCAE v 3.0) | Frequency and Severity of Observed Adverse Effects | Constitutional | 0 Participants |
| Grade 3 (CTCAE v 3.0) | Frequency and Severity of Observed Adverse Effects | Dermatologic | 0 Participants |
| Grade 3 (CTCAE v 3.0) | Frequency and Severity of Observed Adverse Effects | Gastrointestinal | 2 Participants |
| Grade 3 (CTCAE v 3.0) | Frequency and Severity of Observed Adverse Effects | Hemorrhage | 0 Participants |
| Grade 3 (CTCAE v 3.0) | Frequency and Severity of Observed Adverse Effects | Lymphatics | 0 Participants |
| Grade 3 (CTCAE v 3.0) | Frequency and Severity of Observed Adverse Effects | Metabolic | 2 Participants |
| Grade 3 (CTCAE v 3.0) | Frequency and Severity of Observed Adverse Effects | Musculoskeletal | 0 Participants |
| Grade 3 (CTCAE v 3.0) | Frequency and Severity of Observed Adverse Effects | Ocular/Visual | 0 Participants |
| Grade 3 (CTCAE v 3.0) | Frequency and Severity of Observed Adverse Effects | Pain | 2 Participants |
Primary
Tumor Response
Complete and Partial Tumor Response by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0). Per RECIST v1.0 for target lesions and assessed by MRIor CT scan: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. CT scan or MRI if used to follow lesion for measurable disease every other cycle for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels. Responses must be confirmed by repeat imaging 4 weeks following documentation of response.
Time frame: every other cycle for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels
Population: Eligible and Treated Patients
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Abraxane® | Tumor Response | 23.4 Percentage of participants |
Secondary
Overall Survival
Time frame: from entry into the study to death or the date of last contact.
Population: Eligible and Treated Patients
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Abraxane® | Overall Survival | 17.4 months |
Secondary
Progression-free Survival
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since study entry, or unequivocal progression of existing non-target lesions, or the appearance of one or more new lesions. CT scan or MRI if used to follow lesion for measurable disease every other cycle for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels. Responses must be confirmed by repeat imaging 4 weeks following documentation of response.
Time frame: from study entry until disease progression, death or date of last contact.
Population: Eligible and Treated Patients
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Abraxane® | Progression-free Survival | 4.5 months |