Clinical trial · Interventional
Erlotinib and Chemotherapy for 2nd Line Treatment (Tx) of Metastatic Colorectal Cancer (mCRC)
Phase II Study of Erlotinib (Tarceva) Alternating With Chemotherapy for Second-line Treatment of Metastatic Colorectal Cancer With Molecular Correlates for p53 Pathway
NCT00642746CI-TRIAL-00015710terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Terminated due to poor enrollment and grade 3 toxicities noted during an interim analysis.
Summary
Brief summary (as posted)
The purpose of this study is to see if alternating chemotherapy with erlotinib increases tumor shrinkage in people with metastatic colorectal cancer. The investigator will also be studying the side effects (good and bad) of alternating chemotherapy with erlotinib on metastatic colorectal 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 |
|---|---|---|---|
| Metastatic Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Erlotinib | Drug | Erlotinib | ALIAS |
| Fluorouracil | Drug | Fluorouracil | ALIAS |
| Irinotecan | Drug | Irinotecan | ALIAS |
| Leucovorin | Drug | Leucovorin | ALIAS |
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- FOLFOX with Erlotinib
- description
- Subjects received FOLFOX (Leucovorin, Fluorouracil, and Oxaliplatin) and Erlotinib. Treatment consisted of a 28 day cycle. Subjects received FOLFOX on days 1, 2, and 3, and 15-16, followed by Erlotinib on days 3-8, and 17-22.
- interventionNames
- Drug: Erlotinib
- Drug: Fluorouracil
- Drug: Leucovorin
- Drug: Oxaliplatin
- type
- EXPERIMENTAL
- label
- FOLFIRI with Erlotinib
- description
- Subjects received FOLFIRI (Leucovorin, Fluorouracil, and Irinotecan) and Erlotinib. Treatment consisted of a 28 day cycle. Subjects received FOLFIRI on days 1, 2, and 3, and 15-16, followed by Erlotinib on days 3-8, and 17-22.
- interventionNames
- Drug: Erlotinib
- Drug: Fluorouracil
- Drug: Leucovorin
- Drug: Irinotecan
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: Patients must fulfill all of the following criteria to be eligible for study entry: * Age 18-80 * Able to provide informed consent * Biopsy proven unresectable metastatic adenocarcinoma of the colon or rectum * Documented progression on prior first-line oxaliplatin-based or irinotecan-based regimen for metastatic colorectal cancer * Radiographically measurable disease with at least one bidimensionally measurable lesion of \> 1 cm * Prior first-line regimen must have been completed at least 4 weeks prior to study treatment * Use of biologic agents with first-line chemotherapy permitted * Previous adjuvant regimens must have been greater than 6 months before inclusion * Adequate organ function including bone marrow, liver and renal function as defined by the following values: absolute neutrophil count \> 1500/microliter; Hgb \> 9 g/dL; platelets \> 90,000/microliter; International Normalized Ratio \< 1.8 (unless in therapeutic range if taking warfarin or other warfarin-derivative anticoagulants and are being monitored regularly for changes in prothrombin time or International Normalized Ratio); bilirubin \< 2 times the Upper Limit of Normal; alkaline phosphatase \< 3 times the Upper Limit of Normal; aspartate aminotransferase/alanine aminotransferase \< 5 times the Upper Limit of Normal; serum creatinine \< 1.5 times the Upper Limit of Normal * Eastern Cooperative Oncology Group status \< 2 Exclusion Criteria: Patients meeting any of the following criteria are ineligible for study entry: * Prior second-line chemotherapy regimens for colorectal cancer * Prior treatment with erlotinib or gefitinib * Central Nervous System metastasis * Second malignancies less than 5 years prior to enrollment. Completely resected basal or squamous cell carcinoma of the skin is allowed. * Untreated/unresolved bowel obstruction * Inability to take oral mediations * HIV positive * Pregnancy * Other uncontrolled medical illnesses * Current diarrhea \> grade 2 * Symptomatic angina or uncontrolled congestive heart failure
References
Publications (0)
Data not yet available
No reference posted for this study.