Ovarian Cancer Clinical Trial

Gemcitabine and Docetaxel in Treating Patients With Relapsed or Refractory Ovarian Epithelial or Peritoneal Cancer

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. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

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.

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Full 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 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.

View Eligibility Criteria

Eligibility Criteria

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

Study is for people with:

Ovarian Cancer

Phase:

Phase 2

Estimated Enrollment:

30

Study ID:

NCT00227721

Recruitment Status:

Completed

Sponsor:

Robert Morris

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There are 4 Locations for this study

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Oakwood Cancer Center at Oakwood Hospital and Medical Center
Dearborn Michigan, 48123, United States
Barbara Ann Karmanos Cancer Institute
Detroit Michigan, 48201, United States
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
Columbus Ohio, 43210, United States
Northern Virginia Pelvic Surgery Assoc
Annandale Virginia, 22003, United States

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Phase:

Phase 2

Estimated Enrollment:

30

Study ID:

NCT00227721

Recruitment Status:

Completed

Sponsor:


Robert Morris

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