Status:
WITHDRAWN
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
Lead Sponsor:
Gynecologic Oncology Group
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Fallopian Tube Cancer
Ovarian Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: 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. Giv...
Detailed Description
OBJECTIVES: Primary * Determine the progression-free survival of patients with persistent or recurrent platinum-sensitive ovarian epithelial, fallopian tube, or primary peritoneal cancer treated wit...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00369954
Start Date
April 1 2006
Last Update
June 10 2013
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