Doxorubicin and Gemcitabine in Treating Patients With Locally Recurrent or Metastatic Unresectable Renal Cell Carcinoma
Condition: Metastatic Renal Cell Carcinoma; Renal Cell Carcinoma With Sarcomatoid Features
MeSH terms: Carcinoma; Carcinoma, Renal Cell
Intervention: Doxorubicin; Gemcitabine; G-CSF (granulocyte-colony stimulating factor); Neulasta
Intervention description: Doxorubicin: 50 mg/m² IV slow push followed by gemcitabine 1500 mg/m² IV infusion over 30 minutes on day 1. Cycles repeat every 2 weeks.; Doxorubicin: 50 mg/m² IV slow push followed by gemcitabine 1500 mg/m² IV infusion over 30 minutes on day 1. Cycles repeat every 2 weeks.; Patients will receive G-CSF at a subcutaneous dose of 5mcg/kg/day on days 2 or 3 to 10 or neulasta at a dose of 6mg on day 2. Growth factor must be administered as close as possible to 24 hours after the completion of chemotherapy. It is recommended that neulasta be administered only on day 2 due to its prolonged half-life.; Patients will receive G-CSF at a subcutaneous dose of 5mcg/kg/day on days 2 or 3 to 10 or neulasta at a dose of 6mg on day 2. Growth factor must be administered as close as possible to 24 hours after the completion of chemotherapy. It is recommended that neulasta be administered only on day 2 due to its prolonged half-life.
Intervention MeSH terms: Gemcitabine; Doxorubicin; Lenograstim
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 39.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Sarcomatoid; Gemcitabine; Doxorubicin; Renal cell cancer; Kidney cancer

Summary:

      RATIONALE: Drugs used in chemotherapy, such as doxorubicin and gemcitabine, use different
      ways to stop tumor cells from dividing so they stop growing or die. Combining more than one
      drug may kill more tumor cells.

      PURPOSE: This phase II trial is studying how well giving doxorubicin together with
      gemcitabine works in treating patients with locally recurrent or metastatic unresectable
      renal cell carcinoma (kidney cancer).
    

Eligibility criteria:

        INCLUSION CRITERIA:

          -  Histologically confirmed renal cell carcinoma

               -  Features must be of sarcomatoid histology

               -  Locally recurrent or metastatic disease not amenable to resection

          -  Measurable disease

          -  Must have a prior nephrectomy provided all other eligibility criteria are met, and
             adequately recovered from any recent surgery

          -  At least 4 weeks since prior radiotherapy and recovered

          -  ECOG performance status of 0-1

          -  WBC greater than 3,000/mm^3 or absolute neutrophil count greater than 1,500/mm^3

          -  Platelet count greater than 100,000/mm^3

          -  Bilirubin less than 1.5 mg/dL

          -  Aspartate aminotransferase (AST) less than 2 times upper limit of normal

          -  Creatinine no greater than 2.0 mg/dL

          -  LVEF at least lower limit of normal by MUGA

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  Other prior malignancy allowed provided patient was curatively treated and has been
             disease free from that cancer

          -  Age of 18 and over

          -  Diagnostic material from the kidney or metastatic site biopsy available for central
             pathologic review

        EXCLUSION CRITERIA:

          -  Prior treatment for advanced disease

          -  Previously irradiated lesions as the sole site of disease for patients with prior
             radiation therapy

          -  Concurrent local radiotherapy for pain control or for life-threatening situations

          -  Myocardial infarction within the past year

          -  Congestive heart failure within the past year

          -  Significant ischemic or valvular heart disease within the past year

          -  Prior or concurrent brain metastases

          -  Concurrent serious medical illness that would preclude study treatment

          -  Active infection that would preclude study treatment

          -  Pregnant or nursing