Title
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
A Phase II Trial of Intravenous Gemcitabine (NSC #613327) and Intraperitoneal Carboplatin (NSC # 241240) in the Treatment of Patients With Platinum-Sensitive Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Carcinoma With Non-Measurable Disease
Phase
Phase 2Lead Sponsor
Gynecologic Oncology GroupStudy Type
InterventionalStatus
WithdrawnIndication/Condition
Fallopian Tube Cancer Ovarian Cancer Peritoneal Cavity CancerIntervention/Treatment
gemcitabine carboplatin ...Study Participants
0RATIONALE: Drugs used in chemotherapy, such as gemcitabine and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) and giving them in different ways may kill more tumor cells.
PURPOSE: This phase II trial is studying the side effects and how well giving gemcitabine together with carboplatin works in treating patients with persistent or recurrent ovarian epithelial cancer, primary peritoneal cancer, or fallopian tube cancer that responded to previous cisplatin or carboplatin.
OBJECTIVES:
Primary
Determine the progression-free survival of patients with persistent or recurrent platinum-sensitive ovarian epithelial, fallopian tube, or primary peritoneal cancer treated with gemcitabine hydrochloride and intraperitoneal carboplatin.
Evaluate the systemic and regional toxicity of this regimen in these patients.
Secondary
Determine the overall survival of patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive gemcitabine hydrochloride IV over 30 minutes followed by intraperitoneal carboplatin on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 3 years.
PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study.
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
