PLATINUM-SENSITIVE, RECURRENT OVARIAN, PERITONEAL PRIMARY AND FALLOPIAN TUBE CANCER
Conditions
Interventions
Paclitaxel(175mg/m2) day1 + Carboplatin(AUC5) day1 q21days 6-8cycles
Paclitaxel(175mg/m2) day1 + Carboplatin(AUC5) day1 + Bevacizumab(15mg/kg) day1 q21days 6-8cycles, followed by Bevacizumab(15mg/kg)
d8+ Carboplatin AUC 4 day 1 q21days 6-8cycles
Gemcitabine 1000mg/m2 d1 &
d8+ Carboplatin AUC 4 day 1 + Bevacizumab(15mg/kg) day1 q21days 6-8cycles, followed by Bevacizumab(15mg/kg) q21days until progression
Cytoreductive surgery, then, Gemcitabine 1000mg/m2 d1 &
d8+ Carboplatin AUC 4 day 1 q21days 6-8cycles
Cytoreductive surgery, then, Gemcitabine 1000mg/m2 d1 &
d8+ Carboplatin AUC 4 day 1 q21days 6-8cycles , then, Bevacizumab(15mg/kg) q21days
Sponsors
Gynecologic Oncology Group
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1)Patients enrolled after August 28, 2011 must be candidates for cytoreductive surgery and consent to have their surgical treatment determined by randomization. 2)Patients must have histologic diagnosis of epithelial ovarian carcinoma, peritoneal primary or Fallopian tube carcinoma, which is now recurrent. 3)Patients with the following histologic epithelial cell types are eligible: Serous adenocarcinoma, endometrioid adenocarcinoma, mucinous denocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, transitional cell carcinoma, malignant Brenner's Tumor, or adenocarcinoma not otherwise specified. 4)Patients must have had a complete response to front-line platinum-taxane therapy (at least 3 cycles). 5)Patients must have recurrence documented by clinically evident measurable recurrent disease. 6)ANC greater than or equal to 1,500/mm3 7)PLT greater than or equal to 100,000/mm3. 8)Creatinine(non-IDMS) less than or equal to 1.5 x institutional upper limit normal(ULN),CTCAE G1 9)Total bilirubin less than or equal to 1.5 x ULN 10)SGOT/AST and ALP less than or equal to 2.5 times the upper limit of normal in the absence of liver metastasis. SGOT/AST and ALP <5.0 times ULN in the presence of liver metastasis. 11)UPCR < 1.0mg/dL. 12) (This eligibility criterion does not apply to patients enrolled after August 7, 2011).Patients who are not candidates for surgical cytoreduction are eligible for the chemotherapy randomization. Patients are not considered candidates for surgical cytoreduction if complete cytoreduction in the estimation of the investigator is impossible or a medical infirmity precludes exploration and debulking. 13)Patients must have met the pre-entry requirements specified in protocol Section 7.0. 14)Patients must have signed an approved informed consent and authorization permitting release of personal health information. 15)GOG PS: 0-2 16)Age: 18 or older
Exclusion criteria
Exclusion criteria: 1)More than 1 previous regimen of chemo 2)Receiving concurrent immunotherapy or radiotherapy 3)Prior radiotherapy to any portion of the abdominal cavity or pelvis 4)Evidence of partial bowel obstruction or perforation 5)Prior chemo for any abdominal or pelvic tumor 6)Synchronous primary endometrial cancer, or a past history of primary endometrial cancer 7)Secondary cytoreduction for recurrent disease 8)Uncontrolled infection 9)Concurrent severe medical problems unrelated to the malignancy 10)More than grade2 peripheral neuropathy 11)History of allergic reactions to carboplatin and/or paclitaxel or chemically similar compounds. 12)Hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies. 13)Childbearing potential, not practicing adequate contraception, pregnant or nursing 14)Other invasive malignancies, with the exception of non-melanoma skin cancer, within the last 5 yrs 15)Active bleeding or pathologic conditions that carry high risk of bleeding 16)History or evidence upon physical examination of CNS disease 17)Significant cardiac conduction abnormalities 18)Uncontrolled hypertension, defined as systolic >150mmHg or diastolic >90mmHg 19)Myocardial infarction, cardiac arrhythmia or unstable angina < 6mo prior to registration 20)NYHA Grade2 or greater congestive heart failure 21)Serious cardiac arrhythmia requiring medication 22)Grade2 or greater peripheral vascular disease 23)History of CVA within 6mo 24)Patients who have had a major surgical procedure, open biopsy, dental extractions or other dental surgery/procedure that results in an open wound, or significant traumatic injury within 28days prior to the treatment on this study, or anticipation of need for major surgical procedure during the course of the study; patients with placement of vascular access device or core biopsy within 7days prior to the treatment on this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-Free Survival, Adverse Event | — |
Countries
Japan,Asia(except Japan),North America
Contacts
Public ContactKeiichi Fujiwara, MD.,PhD
Saitama Medical University International Medical Center Department of Gynecologic Oncology
Outcome results
None listed