Clinical trial · Interventional
Erlotinib and Sirolimus for the Treatment of Metastatic Renal Cell Carcinoma
A Phase II Single Arm Clinical Trial to Evaluate the Efficacy and Safety of the Combination of Tarceva™ (Erlotinib Hydrochloride) and Rapamune™ (Sirolimus) in the Treatment of Metastatic Renal Cell Carcinoma.
NCT00353301CI-TRIAL-00014242completedPhase 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)
The purpose of this study is to test the safety and efficacy of the combination of erlotinib hydrochloride (Tarceva™) and sirolimus (Rapamune™) in the treatment of patients with metastatic kidney cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Renal Cell Carcinoma | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Erlotinib hydrochloride | Drug | Erlotinib Hydrochloride | ALIAS |
| Sirolimus | Drug | Sirolimus | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Erlotinib and Sirolimus
- description
- Erlotinib hydrochloride (Tarceva) will be self-administered in an open-label unblinded manner to all patients enrolled in the study. During the treatment period, patients will receive single-agent Tarceva, 150 mg/day. Sirolimus (Rapamune) will be self-administered in an open-label unblinded manner to all patients enrolled in the study. Patients will receive a loading dose of 6 mg of Rapamune seven days after beginning treatment with Tarceva™ followed by a dose of 2mg/day.
- interventionNames
- Drug: Erlotinib hydrochloride
- Drug: Sirolimus
Primary outcomes (1)
- measure
- Progression-free Survival
- timeFrame
- Physical exam assessments were performed every 4 weeks during the treatment phase. Survival follow-up information was collected every 4 months following the termination visit until death, loss to follow-up, or study termination up to 275 weeks.
- description
- Time to progression was defined as the time from beginning of therapy until disease progression or death. For subjects who had not progressed at the time of statistical analysis, progression-free survival was censored at the date of their last tumor assessment. Kaplan-Meier method was used to estimate median progression-free survival. Progression was defined as radiographic progression according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria (year 2000 version), non-compliance in obtaining scans, unequivocal clinical progression or the initiation of another medication for the treatment of renal cell carcinoma.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Signed informed consent to participate in this study. * Histological diagnosis of renal cell carcinoma. * Age greater or equal 18 years. * Eastern Cooperative Oncology Group (ECOG) Performance status of 2 or better. * Life expectancy of at least 3 months. * Failure or intolerance to previous treatment with Sutent® and/or Nexavar®. * Most recent systemic treatment at least 1 month from the beginning of treatment. * Most recent local treatment (surgery or irradiation) \> 2 weeks from the beginning of treatment. * At least one site of measurable disease by CT scan or MRI (RECIST criteria). * Baseline hemoglobin \>9 g/dl, platelets \> 100,000/mm3, absolute neutrophil count (ANC \>1500/mm3. Exclusion Criteria: * Previous treatment with Tarceva™, Iressa™, Rapamune™, temsirolimus or everolimus. * Untreated metastasis to the central nervous system. * Previous solid organ, bone marrow or stem-cell transplant. * Known AIDS or HIV infection. * Symptomatic or poorly controlled chronic heart failure. * Chronic renal failure requiring dialysis on a regular basis. * Chronic liver failure. * Serum aspartate aminotransferase (AST), Alanine Aminotransferase (ALT), alkaline phosphatase or bilirubin \>1.5 x the upper limit of normal for the local laboratory. * Pregnant or breast-feeding women. * Other invasive malignant diseases within 5 years (other than squamous or basal cell carcinoma of the skin). * Inability to provide informed consent * Any other serious and/or unstable medical, psychiatric, or other condition considered by the P.I. to preclude safe or reasonably compliant participation in the protocol.
References
Publications (1)
- BACKGROUNDGemmill RM, Zhou M, Costa L, Korch C, Bukowski RM, Drabkin HA. Synergistic growth inhibition by Iressa and Rapamycin is modulated by VHL mutations in renal cell carcinoma. Br J Cancer. 2005 Jun 20;92(12):2266-77. doi: 10.1038/sj.bjc.6602646. PMID 15956968