Gemcitabine and Carboplatin in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer That Responded to Previous Cisplatin or Carboplatin
Fallopian Tube Cancer, Ovarian Cancer, Peritoneal Cavity Cancer
About this trial
This is an interventional treatment trial for Fallopian Tube Cancer focused on measuring recurrent ovarian epithelial cancer, fallopian tube cancer, peritoneal cavity cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed ovarian epithelial cancer, primary peritoneal cancer, or fallopian tube cancer Persistent or recurrent disease Nonmeasurable disease Platinum-sensitive disease Must have attained a clinically defined complete response after prior platinum- (cisplatin or carboplatin) and taxane-based combination chemotherapy regimen Patients with partial response or disease progression after first-line therapy are not eligible No disease recurrence within 6 months after completion of first-line platinum-taxane therapy Must have undergone laparoscopy or laparotomy for either of the following: Second-look surgery after a complete response to first-line therapy No negative second-look surgery Secondary cytoreductive surgery for recurrent disease ≥ 6 months after completion of first-line chemotherapy No greater than 1 cm residual disease at the completion of laparoscopy or laparotomy AND no diffuse carcinomatosis Disease must be confined to the peritoneal cavity Retroperitoneal disease ≤ 1 cm at the completion of prior surgery allowed Not a candidate for a higher priority GOG protocol No tumors of low malignant potential PATIENT CHARACTERISTICS: GOG performance status 0-2 Absolute neutrophil count ≥ 1,500/mm³ Platelet count ≥ 100,000/mm³ Creatinine ≤ 1.5 times upper limit of normal (ULN) Bilirubin ≤ 1.5 times ULN SGOT ≤ 2.5 times ULN Alkaline phosphatase ≤ 2.5 times ULN Neuropathy (sensory and motor) ≤ grade 1 Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No active infection requiring antibiotics No other invasive malignancies within the past 5 years except nonmelanoma skin cancer No extensive intra-abdominal adhesions PRIOR CONCURRENT THERAPY: See Disease Characteristics Recovered from prior surgery or chemotherapy No prior intraperitoneal therapy No prior gemcitabine hydrochloride No more than 1 prior regimen (including consolidation chemotherapy) for ovarian epithelial cancer, primary peritoneal cancer, or fallopian tube cancer No radiotherapy to > 25% of marrow-bearing areas No prior abdominal-pelvic radiotherapy No prior cancer treatment that would preclude study therapy No other prior therapy directed at the malignant tumor, including biological agents (unless this was part of front-line therapy), immunologic agents, vaccines, second-line chemotherapy, or hormonal therapy Concurrent hormone replacement therapy allowed No concurrent amifostine or other protective reagents