Gemcitabine and Docetaxel in Treating Patients With Relapsed or Refractory Ovarian Epithelial or Peritoneal Cancer
NCT ID: NCT00227721
Last Updated: 2020-12-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
30 participants
INTERVENTIONAL
2004-02-29
2017-02-28
Brief Summary
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PURPOSE: This phase II trial is studying how well giving gemcitabine together with docetaxel works in treating patients with relapsed or refractory ovarian epithelial or peritoneal cancer.
Detailed Description
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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 docetaxel.
Secondary
* Determine the toxicity of this regimen in these patients.
* Determine the overall survival of patients treated with this regimen.
* Determine the time to treatment failure and progression-free survival of patients treated with this regimen.
OUTLINE: This is a multicenter study. Patients are stratified according to response to prior treatment with a platinum-containing regimen (platinum-resistant disease vs platinum-sensitive disease).
Patients receive gemcitabine IV over 30 minutes and docetaxel IV over 30 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 3 additional courses beyond CR (≥ 6 total courses of treatment).
PROJECTED ACCRUAL: Approximately 36-62 patients (19-29 for stratum I \[platinum-resistant disease\] and 17-33 for stratum II \[platinum-sensitive disease\]) will be accrued for this study.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Docetaxel & Gemcitabine hydrochloride
Docetaxel, 40 mg/m2, 30 min IV infusion on Days 1 and 8, of a 21 day cycle Gemcitabine hydrochloride, 800mg/m2 30 min IV infusion on Days1 and 8, of a 21 day cycle
Docetaxel
40 mg/m2, 30 minute IV infusion, Days 1 and 8, Every 21 days
Gemcitabine hydrochloride
800mg/m2, 30 minute IV infusion, Days 1 and 8, every 21 days
Interventions
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Docetaxel
40 mg/m2, 30 minute IV infusion, Days 1 and 8, Every 21 days
Gemcitabine hydrochloride
800mg/m2, 30 minute IV infusion, Days 1 and 8, every 21 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
120 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Robert Morris
OTHER
Responsible Party
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Robert Morris
Principal Investigator
Principal Investigators
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Robert T. Morris, MD
Role: PRINCIPAL_INVESTIGATOR
Barbara Ann Karmanos Cancer Institute
Locations
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Oakwood Cancer Center at Oakwood Hospital and Medical Center
Dearborn, Michigan, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
Columbus, Ohio, United States
Northern Virginia Pelvic Surgery Assoc
Annandale, Virginia, United States
Countries
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Related Links
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Clinical trial summary from the National Cancer Institute's PDQ® database
Other Identifiers
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WSU-C-2713
Identifier Type: -
Identifier Source: secondary_id
CDR0000445432
Identifier Type: -
Identifier Source: org_study_id