Evaluation of Oxaliplatin and Gemcitabine in Patients With Metastatic Bladder Cancer
Condition: Carcinoma, Transitional Cell
MeSH terms: Urinary Bladder Neoplasms; Carcinoma, Transitional Cell
Intervention: Oxaliplatin with Gemcitabine
Intervention description: Oxaliplatin will be given as an intravenous infusion over 60 minutes on Days 1 and 14 at a dose of 100 mg/m2 for each cycle. Gemcitabine (1000 mg/m2) will be given on days 1 and 14 as an intravenous infusion over 30 minutes immediately prior to Oxaliplatin.
Intervention MeSH terms: Gemcitabine; Oxaliplatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 17.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Carcinoma, Transitional Cell; Bladder Cancer; oxaliplatin; Gemcitabine

Summary:

      This phase II trial evaluated the impact of Oxaliplatin and Gemcitabine in patients with
      recurrent or advanced transitional cell carcinoma of the bladder. The combination of
      Oxaliplatin and Gemcitabine is considered investigational and this study will help in
      determining if their activity and toxicity profiles are comparable or better than the
      standard regimens.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All patients must have histologically or cytologically confirmed diagnosis of
             transitional cell carcinoma of the bladder.

          -  Patients must have metastatic or locally recurrent transitional cell carcinoma of the
             bladder. Patients with locoregional disease must be considered incurable by means of
             locoregional therapy.

          -  All sites of disease must be assessed and designated as measurable or non- measurable
             disease as documented by CT, MRI, X-ray physical exam or nuclear exam. All measurable
             disease must be assessed within 28 days prior to registration. All non-measurable
             disease must be assessed within 42 days prior to registration.

          -  Patients must not have more than one prior chemotherapy regimen for
             recurrent/metastatic disease. Patients with initial locally advanced but nonmetastatic
             disease are allowed to have one prior chemotherapy regimen as part of the primary
             curative therapy. All chemotherapy must be completed 4 weeks prior to registration.
             Any number of prior biologic therapies (e.g. chimeric antibodies or kinase inhibitors)
             is permitted as part of the chemotherapy regimen.

          -  Patients may have received prior radiotherapy if there has been complete recovery from
             all radiation-induced toxicities. At least 4 weeks must have elapsed from the
             completion of radiation therapy to the time of registration. If lesions within the
             radiation port are to be used to assess response to therapy, those lesions must have
             demonstrated clear progression by the criteria outlined in Section 10.1.2V following
             completion of radiation therapy.

          -  Patients must not have a surgical procedure for bladder cancer within 4 weeks prior to
             registration. Patients must have completely recovered from all surgery prior to
             registration.

          -  Patients must have adequate bone marrow reserve as evidenced by ANC > 1,500 μl and
             platelets > 100,000/ μl obtained within 14 days prior to registration.

          -  Patients must have adequate hepatic function as evidenced by serum bilirubin <1.5x the
             institutional upper limit of normal. Serum transaminase (SGOT or SGPT) be must < 1.5 x
             the institutional upper limit of normal serum unless the liver is involved with tumor,
             in which case serum transaminase (SGOT or SGPT) must be < 5 x the institutional limit
             of normal. These tests must be obtained within 14 days prior to registration.

          -  Patients must have a creatinine < 2 x the institutional upper limit of normal obtained
             within 14 days prior to registration.

          -  All patients must be 18 years of age or older.

          -  Patients must have a Zubrod performance of 0-2.

          -  Patients must not have prior therapy with Oxaliplatin or Gemcitabine.

        Exclusion Criteria

          -  Patients with severe psychiatric disorder are not eligible.

          -  Patients with known brain metastasis are not eligible. However, brain imaging studies
             are not required for eligibility if the patient has no neurological signs or symptoms.
             If brain imaging studies are performed, they must be negative for disease.

          -  No other prior malignancy is allowed except for adequately treated basal cell or
             squamous cell carcinoma, in situ cervical cancer, or adequately treated Stage I and II
             cancer from which the patient is in complete remission, or any other malignancy from
             which the patient has been disease-free for 5 years.

          -  Patients with any evidence of active or uncontrolled infection, recent myocardial
             infarction, unstable angina, or life-threatening arrhythmia are not eligible.

          -  Patients with any evidence of active or uncontrolled infection, recent myocardial
             infarction, unstable angina, or life-threatening arrhythmia are not eligible.

          -  Patients with severe psychiatric disorder are not eligible.

          -  Patients with known brain metastasis are not eligible. However, brain imaging studies
             are not required for eligibility if the patient has no neurological signs or symptoms.
             If brain imaging studies are performed, they must be negative for disease.

          -  No other prior malignancy is allowed except for adequately treated basal cell or
             squamous cell carcinoma, in situ cervical cancer, or adequately treated Stage I and II
             cancer from which the patient is in complete remission, or any other malignancy from
             which the patient has been disease-free for 5 years.