At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed renal cell carcinoma with sarcomatoid features
- ✓Locally recurrent or metastatic disease not amenable to resection
- ✓Prior nephrectomy required, with adequate recovery from surgery
- ✓Measurable disease
- ✕Prior treatment for advanced disease
- ✕Previously irradiated lesions as sole site of disease
- ✕Concurrent local radiotherapy for pain control or life-threatening situations
- ✕Myocardial infarction within past year
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase II Trial of Doxorubicin and Gemcitabine in Metastatic Renal Cell Carcinoma With Sarcomatoid Features
In Brief
A Phase 2 clinical trial evaluating Doxorubicin, Gemcitabine, and 2 other interventions for Metastatic Renal Cell Carcinoma and Renal Cell Carcinoma With Sarcomatoid Features. Completed, enrolled 39 participants across 92 sites.
Detailed 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).
Study Details
Timeline
Interventions
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.