Status:
COMPLETED
Gemcitabine and Docetaxel in Treating Patients With Relapsed or Refractory Ovarian Epithelial or Peritoneal Cancer
Lead Sponsor:
Robert Morris
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Ovarian Cancer
Peritoneal Cavity Cancer
Eligibility:
FEMALE
18-120 years
Phase:
PHASE2
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and docetaxel, 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 response rate in patients with platinum-sensitive or -resistant relapsed or refractory ovarian epithelial or peritoneal cavity cancer treated with gemcitabine and...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed ovarian epithelial or peritoneal cavity cancer
- Relapsed or refractory disease after prior first-line therapy with a platinum-containing regimen
- Platinum-sensitive or -resistant disease
- Platinum resistance is defined as relapsed or progressive disease within 6 months after completion of a platinum-containing regimen
- Measurable or evaluable disease
- Evaluable disease is defined as CA 125 \> 70 U/mL that has doubled from a baseline determination confirmed by ≥ 2 separate blood samples taken \> 4 weeks apart OR other evidence demonstrating progressive disease after initial treatment regimen
- PATIENT CHARACTERISTICS:
- Age
- 18 and over
- Performance status
- ECOG 0-2
- Life expectancy
- Not specified
- Hematopoietic
- WBC ≥ 3,000/mm\^3
- Absolute neutrophil count ≥ 1,500/mm\^3
- Platelet count ≥ 100,000/mm\^3
- Hemoglobin ≥ 8.0 g/dL
- Hepatic
- Bilirubin normal
- Meets 1 of the following criteria:
- AST or ALT normal AND alkaline phosphatase (AP) ≤ 5 times upper limit of normal (ULN)
- AST or ALT ≤ 1.5 times ULN AND AP ≤ 2.5 times ULN
- AST or ALT ≤ 5 times ULN AND AP normal
- Renal
- Creatinine clearance \> 30 mL/min
- Creatinine \< 2.5 mg/dL
- Cardiovascular
- No congestive heart failure
- No second or third degree heart block
- No myocardial infarction within the past 3 months
- Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No peripheral neuropathy \> grade 1
- No other malignancy within the past 2 years except adequately treated skin cancer or carcinoma in situ of the cervix
- No history of severe hypersensitivity reaction to drugs formulated with polysorbate 80
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- Not specified
- Chemotherapy
- See Disease Characteristics
- Prior paclitaxel allowed
- No more than 1 prior chemotherapy regimen
- First-line platinum-based chemotherapy followed by consolidation therapy in the setting of a clinical and serologic complete response is considered 1 regimen
- No prior gemcitabine or docetaxel
- Endocrine therapy
- Not specified
- Radiotherapy
- At least 4 weeks since prior radiotherapy and recovered
- Surgery
- Not specified
- Other
- More than 28 days since prior and no other concurrent investigational drugs for this cancer
- No other concurrent treatment or alternative therapy for this cancer
Exclusion
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2017
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00227721
Start Date
February 1 2004
End Date
February 1 2017
Last Update
December 2 2020
Active Locations (4)
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1
Oakwood Cancer Center at Oakwood Hospital and Medical Center
Dearborn, Michigan, United States, 48123-2500
2
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379
3
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
Columbus, Ohio, United States, 43210-1240
4
Northern Virginia Pelvic Surgery Assoc
Annandale, Virginia, United States, 22003