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

• Status: Completed
• Trial end date: 2017-02-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Robert Morris; Robert Morris, M.D.
• Collaborator: National Cancer Institute (NCI)
• Treatments: Docetaxel; Gemcitabine

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