Status:
COMPLETED
Gemcitabine and Topotecan in Treating Patients With Recurrent or Persistent Ovarian, Fallopian Tube, or Primary Peritoneal Cavity Cancer
Lead Sponsor:
Fred Hutchinson Cancer Center
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 topotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Givin...
Detailed Description
OBJECTIVES: Primary * Determine the nature and degree of toxicity of gemcitabine and topotecan in patients with recurrent or persistent platinum-refractory ovarian, fallopian tube, or primary perito...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Diagnosis of ovarian, fallopian tube, or primary peritoneal cavity cancer
- Recurrent or persistent platinum-refractory disease, as defined by 1 of the following:
- Progressive disease while on a platinum compound
- Persistent clinically measurable disease with best response as stable disease at the completion of ≥ 6 courses of therapy
- Recurrent disease within 6 months after completion of therapy
- Measurable or evaluable disease
- Evaluable disease, defined as CA 125 ≥ 100 U/mL (confirmed by 2 blood tests)
- Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques, including palpation, plain x-ray, CT scan, or MRI, OR ≥ 10 mm by spiral CT scan
- PATIENT CHARACTERISTICS:
- Age
- 18 and over
- Performance status
- GOG 0-3
- Life expectancy
- Not specified
- Hematopoietic
- Absolute neutrophil count ≥ 1,500/mm\^3
- Platelet count ≥ 100,000/mm\^3
- Hepatic
- Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- SGOT ≤ 2.5 times ULN
- Alkaline phosphatase ≤ 2.5 times ULN
- Renal
- Creatinine ≤ 1.5 times ULN
- Creatinine clearance \> 50 mL/min
- Other
- No clinically significant infection
- No other severe medical condition that would preclude study treatment
- No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix or breast
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- Not specified
- Chemotherapy
- See Disease Characteristics
- Prior gemcitabine or topotecan allowed provided disease is not refractory to either drug
- At least 3 weeks since prior chemotherapy and recovered
- Endocrine therapy
- Not specified
- Radiotherapy
- At least 3 weeks since prior radiotherapy and recovered
- Surgery
- Recovered from recent prior surgery
Exclusion
Key Trial Info
Start Date :
July 1 2002
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00217555
Start Date
July 1 2002
Last Update
September 21 2010
Active Locations (1)
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1
University of Washington School of Medicine
Seattle, Washington, United States, 98195