Gemcitabine and Docetaxel in Treating Patients With Relapsed or Refractory Ovarian Epithelial or Peritoneal Cancer
Condition: Ovarian Cancer; Peritoneal Cavity Cancer
Intervention: Docetaxel; Gemcitabine hydrochloride
Intervention description: 40 mg/m2, 30 minute IV infusion, Days 1 and 8, Every 21 days; 800mg/m2, 30 minute IV infusion, Days 1 and 8, every 21 days
Intervention MeSH terms: Gemcitabine; Docetaxel
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: Female
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: recurrent ovarian epithelial cancer; peritoneal cavity 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.
    

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