Clinical Trial of Docetaxel in Combination With Gemcitabine in Platinum-Resistant Ovarian Cancer and Primary Peritoneal Carcinoma
Condition: Ovarian Carcinoma; Peritoneal Neoplasms
MeSH terms: Carcinoma; Peritoneal Neoplasms
Intervention: Docetaxel and Gemcitabine
Intervention description: Docetaxel 75 mg/m2 IV over 15-30 minutes on day 1 followed by Gemcitabine 800 mg/m2 IV over 30 minutes on Days 1 and 8 of each 3 weeks (21 days) cycle.
Intervention MeSH terms: Gemcitabine; Docetaxel
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Primary Peritoneal

Summary:

      This study is for patients with advanced ovarian cancer that has reappeared after treatment
      with conventional therapy. The purpose of this study is to determine if the combination of
      docetaxel and gemcitabine will be effective in reducing or eliminating the tumor(s) in
      patients with ovarian cancer.

      Docetaxel is approved by the Food and Drug Administration (FDA) for the treatment of breast
      and lung cancer; gemcitabine is approved by the FDA for the treatment of pancreatic and lung
      cancer. Neither docetaxel nor gemcitabine are approved for the treatment of ovarian cancer.
      Both drugs have been shown to decrease the size of ovarian cancer tumors.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically proven diagnosis of epithelial ovarian ca

          -  Must have platinum-resistant disease. (Defined as progression during the most recent
             platinum-based chemotx or relapse < 6 months after the most recent platinum-based
             chemotx regimen.)

          -  Measurable or evaluable disease. (Patients whose dz is manifested only as an elevated
             CA-125 [greater than or equal to 100] are eligible. If an elevated CA-125 is the only
             manifestation of dz, it must be confirmed on 2 separate times, at least 2 weeks apart.
             Patients with positive cytology only are not eligible.)

          -  Greater than or equal to 18 years of age

          -  GOG performance status less than or equal to 2

          -  AGC/ANC greater than or equal to 1.5; platelets greater than or equal to 100,000;
             hemoglobin (Hgb) greater than or equal to 8.0.

          -  Creatinine less than or equal to 2.0

          -  Total bilirubin less than or equal to upper limit of normal (uln)

          -  SGOT and/or SGPT less than or equal to 2.5 x uln if alkaline phosphatase less than or
             equal to uln, or alkaline phosphatase less than or equal to 4 x uln if transaminases
             are less than or equal to uln. (If both SGOT/SGPT >1.5 x uln and alkaline phosphatase
             > 2.5 x uln, patient is not eligible.)

          -  Fully recovered from acute toxicities secondary to prior treatment (tx)

          -  Signed informed consent

        Exclusion Criteria:

          -  Prior treatment with gemcitabine or docetaxel

          -  Underlying medical, psychiatric, or social conditions that would preclude patient from
             receiving treatment

          -  Peripheral neuropathy greater than or equal to Grade 2

          -  No prior tx with cisplatin or carboplatin