Clinical trial · Interventional
Doxorubicin and Gemcitabine in Treating Patients With Locally Recurrent or Metastatic Unresectable Renal Cell Carcinoma
Phase II Trial of Doxorubicin and Gemcitabine in Metastatic Renal Cell Carcinoma With Sarcomatoid Features
NCT00068393CI-TRIAL-00067859completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Renal Cell Carcinoma | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
| Renal Cell Carcinoma With Sarcomatoid Features | Sarcomatoid Renal Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Doxorubicin | Drug | Doxorubicin | ALIAS |
| G-CSF (granulocyte-colony stimulating factor) | Drug | — | UNRESOLVED |
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| Neulasta | Drug | Pegfilgrastim | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Doxorubicin/Gemcitabine
- description
- Doxorubicin was given at 50 mg/m² by IV slow push, followed by gemcitabine 1500 mg/m² IV infusion over 30 minutes on day 1. 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. Cycles were repeated every 2 weeks.
- interventionNames
- Drug: Doxorubicin
- Drug: Gemcitabine
- Drug: G-CSF (granulocyte-colony stimulating factor)
- Drug: Neulasta
Primary outcomes (1)
- measure
- Response Rate by Solid Tumor Response Criteria (RECIST)
- timeFrame
- Every 8 weeks during treatment; then every 3 months if <2 years from study entry; then every 6 months if 2-3 years from study entry
- description
- Per RECIST criteria, Complete response (CR)= disappearance of all target and nontarget lesions Partial response (PR)= \>=30% decrease in the sum of the longest diameters of target lesions from baseline, and persistence of one or more non-target lesion(s) and/or the maintenance of tumor marker level above the normal limits. Objective response = CR + PR
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- RESULTHaas N, Manola J, Pins M, et al.: ECOG 8802: phase II trial of doxorubicin (Dox) and gemcitabine (Gem) in metastatic renal cell carcinoma (RCC) with sarcomatoid features. [Abstract] J Clin Oncol 27 (Suppl 15): A-5038, 2009.
- RESULTHaas NB, Lin X, Manola J, Pins M, Liu G, McDermott D, Nanus D, Heath E, Wilding G, Dutcher J. A phase II trial of doxorubicin and gemcitabine in renal cell carcinoma with sarcomatoid features: ECOG 8802. Med Oncol. 2012 Jun;29(2):761-7. doi: 10.1007/s12032-011-9829-8. Epub 2011 Feb 6. PMID 21298497