Doxorubicin and Gemcitabine in Treating Patients With Locally Recurrent or Metastatic Unresectable Renal Cell Carcinoma

• Status: Completed
• Trial end date: 2011-05-01
• Target enrollment: 0
• Participant gender: All

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).

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

Details

• Lead Sponsor: Eastern Cooperative Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Doxorubicin; Gemcitabine; Lenograstim; Liposomal doxorubicin; Mitogens; Sargramostim

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