Fallopian Tube Cancer, Ovarian Cancer, Peritoneal Cavity Cancer
Conditions
Keywords
stage III ovarian epithelial cancer, peritoneal cavity cancer, fallopian tube cancer
Brief summary
RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining paclitaxel, cisplatin, and liposomal doxorubicin in treating women who have undergone surgery for stage III ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.
Detailed description
OBJECTIVES: * Determine the efficacy of intraperitoneal (IP) cisplatin, IP and IV paclitaxel, and IV doxorubicin HCl liposome, in terms of progression-free survival and overall survival, in patients with optimally debulked stage III ovarian epithelial, fallopian tube, or primary peritoneal cancer. * Determine the feasibility of and toxic effects associated with this regimen in these patients. OUTLINE: This is a multicenter study. Patients receive paclitaxel IV over 3 hours on day 1, intraperitoneal (IP) cisplatin over 30-60 minutes on day 2, IP paclitaxel over 30-60 minutes on day 8, and doxorubicin HCl liposome IV over 1 hour on day 8. Patients not able to tolerate IP infusion receive paclitaxel IV and cisplatin IV on day 1 only. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 6 months for 2 years and then annually thereafter. PROJECTED ACCRUAL: A total of 62 patients will be accrued for this study within 4 years.
Interventions
DRUGcisplatin
DRUGliposomal doxorubicin
DRUGpaclitaxel
Sponsors
National Cancer Institute (NCI)
SWOG Cancer Research Network
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Histologically confirmed stage III ovarian epithelial, fallopian tube, or primary peritoneal carcinoma * Tumor involves one or both ovaries with microscopically confirmed peritoneal metastasis outside the pelvis and/or regional lymph node metastasis * No tumors of borderline or low malignant potential only * Mixed Mullerian tumors allowed * Must have optimal disease defined as no residual lesions after resection or residual disease such that no single lesion measures greater than 1 cm in diameter * Must have undergone staging exploratory laparotomy with tumor debulking within the past 70 days PATIENT CHARACTERISTICS: Age: * Not specified Performance status: * SWOG 0-1 Life expectancy: * Not specified Hematopoietic: * Granulocyte count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 Hepatic: * Bilirubin ≤ 2 times upper limit of normal (ULN) * SGOT or SGPT ≤ 2 times ULN Renal: * Creatinine clearance ≥ 50 mL/min Cardiovascular: * No congestive heart failure * No cardiac arrhythmia * No myocardial infarction or unstable angina within the past 6 months * Patients with a history of myocardial disease must not have ischemia or pathologic arrhythmias and must have an ejection fraction \> 50% by MUGA Other: * Not pregnant or nursing * Fertile patients must use effective contraception * No active or uncontrolled infection * No concurrent fever * No grade 2 or greater sensory neuropathy * No severe gastrointestinal symptoms (i.e., partial obstruction) and/or bleeding, diarrhea, or abdominal tenderness suggestive of peritoneal irritation or infection * No erythema or tenderness of abdominal incision or port site suggestive of underlying infection * No other malignancy within the past five years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior immunotherapy for ovarian cancer Chemotherapy: * No prior chemotherapy for ovarian cancer Endocrine therapy: * Not specified Radiotherapy: * No prior pelvic radiotherapy for ovarian cancer Surgery: * See Disease Characteristics * Recovered from all reversible surgery-related toxic effects Other: * No other concurrent antitumor treatment * No concurrent antibiotics for infection of undetermined etiology
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free Survival | Once a month for 6 months, then every 6 months for up to 2 years, then annually thereafter. | From date of registration to date of progression (as defined per RECIST), symptomatic deterioration or death due to any cause. |
| Overall Survival | Weekly for 6 weeks, then every 6 months for 2 years, then annually thereafter. | from date of registration to date of death due to any cause. Patients last known to be alive wer censored at date of last contact |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | Weekly during 6 weeks of protocol treatment | Only adverse events that are possibly, probably or definitely related to study drug are reported. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Paclitaxel/CDDP/Lipo Doxorubicin intravenous paclitaxel (day 1), intraperitoneal cisplatin (day 2), intraperitoneal paclitaxel and intravenous liposomal doxorubicin (day 8) | 63 |
| Total | 63 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 16 |
| Overall Study | Death | 3 |
| Overall Study | ineligible | 5 |
| Overall Study | Lack of Efficacy | 1 |
| Overall Study | not protocol specified | 3 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Paclitaxel/CDDP/Lipo Doxorubicin |
|---|---|
| Age Continuous | 59 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 58 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 59 Participants |
| Sex: Female, Male Female | 63 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 | 60 / 61 |
| serious Total, serious adverse events | 2 / 61 |
Outcome results
Primary
Overall Survival
from date of registration to date of death due to any cause. Patients last known to be alive wer censored at date of last contact
Time frame: Weekly for 6 weeks, then every 6 months for 2 years, then annually thereafter.
Population: All eligible patients who began the treatment intervention.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Paclitaxel/CDDP/Lipo Doxorubicin | Overall Survival | 51 months |
Primary
Progression-free Survival
From date of registration to date of progression (as defined per RECIST), symptomatic deterioration or death due to any cause.
Time frame: Once a month for 6 months, then every 6 months for up to 2 years, then annually thereafter.
Population: Eligible patients who began the treatment intervention
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Paclitaxel/CDDP/Lipo Doxorubicin | Progression-free Survival | 25 months |
Secondary
Adverse Events
Only adverse events that are possibly, probably or definitely related to study drug are reported.
Time frame: Weekly during 6 weeks of protocol treatment
Population: Paclitaxel/CDDP/Liposomal doxorubicin
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Paclitaxel/CDDP/Lipo Doxorubicin | Adverse Events | Abdominal pain/cramping | 7 Participants |
| Paclitaxel/CDDP/Lipo Doxorubicin | Adverse Events | Allergic reaction | 2 Participants |
| Paclitaxel/CDDP/Lipo Doxorubicin | Adverse Events | Ataxia (incoordination) | 1 Participants |
| Paclitaxel/CDDP/Lipo Doxorubicin | Adverse Events | Bone pain | 1 Participants |
| Paclitaxel/CDDP/Lipo Doxorubicin | Adverse Events | Cardiac ischemia/infarction | 1 Participants |
| Paclitaxel/CDDP/Lipo Doxorubicin | Adverse Events | Catheter related infection | 4 Participants |
| Paclitaxel/CDDP/Lipo Doxorubicin | Adverse Events | Chest pain,not cardio or pleur | 1 Participants |
| Paclitaxel/CDDP/Lipo Doxorubicin | Adverse Events | Confusion | 1 Participants |
| Paclitaxel/CDDP/Lipo Doxorubicin | Adverse Events | Constipation/bowel obstruction | 5 Participants |
| Paclitaxel/CDDP/Lipo Doxorubicin | Adverse Events | Creatinine increase | 1 Participants |
| Paclitaxel/CDDP/Lipo Doxorubicin | Adverse Events | Dehydration | 5 Participants |
| Paclitaxel/CDDP/Lipo Doxorubicin | Adverse Events | Diarrhea without colostomy | 4 Participants |
| Paclitaxel/CDDP/Lipo Doxorubicin | Adverse Events | GU fistula | 1 Participants |
| Paclitaxel/CDDP/Lipo Doxorubicin | Adverse Events | Hand-foot skin reaction | 3 Participants |
| Paclitaxel/CDDP/Lipo Doxorubicin | Adverse Events | Headache | 1 Participants |
| Paclitaxel/CDDP/Lipo Doxorubicin | Adverse Events | Hyperglycemia | 2 Participants |
| Paclitaxel/CDDP/Lipo Doxorubicin | Adverse Events | Hypertension | 1 Participants |
| Paclitaxel/CDDP/Lipo Doxorubicin | Adverse Events | Hypoalbuminemia | 1 Participants |
| Paclitaxel/CDDP/Lipo Doxorubicin | Adverse Events | SGPT (ALT) increase | 1 Participants |
| Paclitaxel/CDDP/Lipo Doxorubicin | Adverse Events | Somnolence/consciousness loss | 1 Participants |
| Paclitaxel/CDDP/Lipo Doxorubicin | Adverse Events | Stomatitis/pharyngitis | 4 Participants |
| Paclitaxel/CDDP/Lipo Doxorubicin | Adverse Events | Thrombocytopenia | 5 Participants |
| Paclitaxel/CDDP/Lipo Doxorubicin | Adverse Events | Thrombosis/embolism | 4 Participants |
| Paclitaxel/CDDP/Lipo Doxorubicin | Adverse Events | Urinary tr infect w/o neutrop | 2 Participants |
| Paclitaxel/CDDP/Lipo Doxorubicin | Adverse Events | Vomiting | 9 Participants |
| Paclitaxel/CDDP/Lipo Doxorubicin | Adverse Events | Weakness (motor neuropathy) | 3 Participants |
| Paclitaxel/CDDP/Lipo Doxorubicin | Adverse Events | Weight loss | 1 Participants |
| Paclitaxel/CDDP/Lipo Doxorubicin | Adverse Events | PRBC transfusion | 5 Participants |
| Paclitaxel/CDDP/Lipo Doxorubicin | Adverse Events | Platelet transfusion | 1 Participants |
| Paclitaxel/CDDP/Lipo Doxorubicin | Adverse Events | Pneumonitis/infiltrates | 1 Participants |
| Paclitaxel/CDDP/Lipo Doxorubicin | Adverse Events | Renal failure | 1 Participants |
| Paclitaxel/CDDP/Lipo Doxorubicin | Adverse Events | Respiratory infect w/ neutrop | 2 Participants |
| Paclitaxel/CDDP/Lipo Doxorubicin | Adverse Events | SGOT (AST) increase | 1 Participants |
| Paclitaxel/CDDP/Lipo Doxorubicin | Adverse Events | Anemia | 5 Participants |
| Paclitaxel/CDDP/Lipo Doxorubicin | Adverse Events | Anorexia | 5 Participants |
| Paclitaxel/CDDP/Lipo Doxorubicin | Adverse Events | Dizziness/light headedness | 1 Participants |
| Paclitaxel/CDDP/Lipo Doxorubicin | Adverse Events | Dyspepsia/heartburn | 1 Participants |
| Paclitaxel/CDDP/Lipo Doxorubicin | Adverse Events | Dyspnea | 2 Participants |
| Paclitaxel/CDDP/Lipo Doxorubicin | Adverse Events | Esophagitis/dysphagia | 1 Participants |
| Paclitaxel/CDDP/Lipo Doxorubicin | Adverse Events | Fatigue/malaise/lethargy | 10 Participants |
| Paclitaxel/CDDP/Lipo Doxorubicin | Adverse Events | Febrile neutropenia | 6 Participants |
| Paclitaxel/CDDP/Lipo Doxorubicin | Adverse Events | GI Mucositis, NOS | 1 Participants |
| Paclitaxel/CDDP/Lipo Doxorubicin | Adverse Events | Hypocalcemia | 1 Participants |
| Paclitaxel/CDDP/Lipo Doxorubicin | Adverse Events | Hypokalemia | 4 Participants |
| Paclitaxel/CDDP/Lipo Doxorubicin | Adverse Events | Hypomagnesemia | 2 Participants |
| Paclitaxel/CDDP/Lipo Doxorubicin | Adverse Events | Hypotension | 1 Participants |
| Paclitaxel/CDDP/Lipo Doxorubicin | Adverse Events | Ileus | 2 Participants |
| Paclitaxel/CDDP/Lipo Doxorubicin | Adverse Events | Infection w/o 3-4 neutropenia | 5 Participants |
| Paclitaxel/CDDP/Lipo Doxorubicin | Adverse Events | Infection with 3-4 neutropenia | 4 Participants |
| Paclitaxel/CDDP/Lipo Doxorubicin | Adverse Events | Infection, unk ANC | 2 Participants |
| Paclitaxel/CDDP/Lipo Doxorubicin | Adverse Events | Insomnia | 1 Participants |
| Paclitaxel/CDDP/Lipo Doxorubicin | Adverse Events | Intestinal fistula | 1 Participants |
| Paclitaxel/CDDP/Lipo Doxorubicin | Adverse Events | Leukopenia | 32 Participants |
| Paclitaxel/CDDP/Lipo Doxorubicin | Adverse Events | Lymphopenia | 16 Participants |
| Paclitaxel/CDDP/Lipo Doxorubicin | Adverse Events | Metabolic-other | 1 Participants |
| Paclitaxel/CDDP/Lipo Doxorubicin | Adverse Events | Myalgia | 1 Participants |
| Paclitaxel/CDDP/Lipo Doxorubicin | Adverse Events | Nausea | 14 Participants |
| Paclitaxel/CDDP/Lipo Doxorubicin | Adverse Events | Neutropenia/granulocytopenia | 35 Participants |