Summary
Erlotinib has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Colorectal Cancer would be drug repurposing rather than first-in-human development. This does not mean it is approved for Colorectal Cancer. ClinicalTrials.gov lists 8 registered trials linking Erlotinib to Colorectal Cancer: 6 have completed; 2 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 2 (NCT00032110). The largest enrolment is 43 participants (NCT00397384). Registration activity spans 2002 to 2017. The literature layer holds 14 publications for this pair: 4 Cochrane reviews, 2 systematic reviews, 3 randomised controlled trial publications and 5 clinical trial publications. Publication years run from 2008 to 2024. Because at least one synthesis-level source exists (systematic review, meta-analysis or Cochrane review), this pair has been assessed beyond single studies, although the synthesis may concern a different indication.
The RepurpOS disease-intelligence file for Colorectal Cancer ranks 1212 candidate therapeutics from Open Targets, ChEMBL, DGIdb and PubMed; only a minority carry direct clinical evidence, and this page covers one of those. Spontaneous remission context recorded for the condition: Essentially zero; 5-year survival stage I: ~90% (resectable); stage IV: ~15% overall, ~20-30% with modern therapy and liver metastasis resection.
Evidence table
| Evidence tier | A · Strong |
|---|---|
| Evidence score | 72.0 (trials 22.0, literature 30.0, tier 15, approved bonus 5.0) |
| Registered trials | 8 total: 0 recruiting, 0 active / not yet recruiting, 6 completed, 2 other |
| Linked publications | 14 (5 clinical trial publications, 4 Cochrane reviews, 3 randomised controlled trial publications, 2 systematic reviews) |
| Agent type | Drug (Small molecule) |
| Development stage (any indication) | Approved |
| Mechanism / class | Not recorded |
| Data sources | DGIdb |
| Linked via biomarker / target | APC |
How the evidence score is calculated
- Each registered trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5). The trial component is capped at 30.
- Each literature item scores by design (Cochrane review 5, meta-analysis 4, systematic review 3, RCT 3, clinical trial publication 2, curated reference 1.5, other PubMed record 1). The literature component is capped at 30.
- The existing evidence tier adds 15 (A / Strong), 10 (B / Moderate), 5 (C / Preliminary) or 0 (D / Anecdotal).
- Agents approved for any indication (max clinical phase 4) add 5, because an approved agent has an established safety profile that lowers the barrier to repurposing trials.
- The score ranks what has been studied, not what works. It does not read effect sizes or directions of effect.
Registered clinical trials
| NCT ID | Title | Status | Phase | Enrolment |
|---|---|---|---|---|
| NCT00940316 | Dual Epidermal Growth Factor Receptor Inhibition With Erlotinib and Panitumumab With or Without Chemotherapy for Advanced Colorectal Cancer 2010 | completed | Phase 2 | 28 |
| NCT03086538 | Pemetrexed Plus Tarceva as Salvage Treatment in EGFR Overexpressed Metastatic Colorectal Cancer Patients Who Were Failed After Standard Chemotherapy 2017 | completed | Phase 2 | 29 |
| NCT00032110 | Erlotinib in Treating Patients With Recurrent or Metastatic Colorectal Cancer 2002 | completed | Phase 2 | 30 |
| NCT00459901 | Study of the Antitumor Activity of Capecitabine in Combination With Erlotinib in Patients With Metastatic Colorectal Cancer 2004 | terminated | Phase 2 | 13 |
| NCT00642746 | Erlotinib and Chemotherapy for 2nd Line Treatment (Tx) of Metastatic Colorectal Cancer (mCRC) 2008 | terminated | Phase 2 | 16 |
| NCT00397384 | Erlotinib Hydrochloride and Cetuximab in Treating Patients With Advanced Gastrointestinal Cancer, Head and Neck Cancer, Non-Small Cell Lung Cancer, or Colorectal Cancer 2007 | completed | Phase 1 | 43 |
| NCT00118261 | Erlotinib, Modified FOLFOX6, and Bevacizumab as First-Line Therapy Metastatic Colorectal Cancer 2005 | completed | Phase 1 | 17 |
| NCT00049101 | Erlotinib and Combination Chemotherapy in Treating Patients With Metastatic Colorectal Cancer 2002 | completed | PHASE1, PHASE2 | — |
Published literature
- Cochrane review Second-line systemic treatment for metastatic colorectal cancer: A systematic review and Bayesian network meta-analysis based on RCTSun C, Fan E, Huang L et al. · PloS one · 2024 · PMID 39715232
- Clinical trial publication A Phase Ib/II Trial of Combined BRAF and EGFR Inhibition in BRAF V600E Positive Metastatic Colorectal Cancer and Other Cancers: The EVICT (Erlotinib and Vemurafenib In Combination Trial) StudyTan L, Tran B, Tie J et al. · Clinical cancer research : an official journal of the American Association for Cancer Research · 2023 · PMID 36638198
- Clinical trial publication Pemetrexed/Erlotinib as a Salvage Treatment in Patients with High EGFR-Expressing Metastatic Colorectal Cancer Following Failure of Standard Chemotherapy: A Phase II Single-Arm Prospective StudyKim ST, Hong JY, Lee J et al. · Targeted oncology · 2020 · PMID 31820199
- Clinical trial publication A Phase II Study Alternating Erlotinib With Second-line mFOLFOX6 or FOLFIRI for Metastatic Colorectal CancerKearney MR, Chen EY, Vaccaro GM et al. · Anticancer research · 2019 · PMID 30591465
- Cochrane review Bevacizumab and erlotinib versus bevacizumab for colorectal cancer treatment: systematic review and meta-analysisKaveh S, Ebrahimi P, Rezapour A et al. · International journal of clinical pharmacy · 2019 · PMID 30610548
- Clinical trial publication A phase II clinical study of combining FOLFIRI and bevacizumab plus erlotinib in 2nd-line chemotherapy for patients with metastatic colorectal cancerZhao Z, Li J, Ye R et al. · Medicine · 2017 · PMID 28746175
- Clinical trial publication Phase II trial of capecitabine plus erlotinib versus capecitabine alone in patients with advanced colorectal cancerVincent MD, Breadner D, Soulieres D et al. · Future oncology (London, England) · 2017 · PMID 28045335
- Cochrane review Survival Benefit and Safety of Bevacizumab in Combination with Erlotinib as Maintenance Therapy in Patients with Metastatic Colorectal Cancer: A Meta-AnalysisXu W, Gong Y, Kuang M et al. · Clinical drug investigation · 2017 · PMID 27665469
- Randomized controlled trial A randomized study of KRAS-guided maintenance therapy with bevacizumab, erlotinib or metronomic capecitabine after first-line induction treatment of metastatic colorectal cancer: the Nordic ACT2 trialHagman H, Frödin JE, Berglund Å et al. · Annals of oncology : official journal of the European Society for Medical Oncology · 2016 · PMID 26483047
- Systematic review Maintenance strategy in metastatic colorectal cancer: A systematic reviewEsin E, Yalcin S · Cancer treatment reviews · 2016 · PMID 26608114
- Randomized controlled trial Bevacizumab with or without erlotinib as maintenance therapy in patients with metastatic colorectal cancer (GERCOR DREAM; OPTIMOX3): a randomised, open-label, phase 3 trialTournigand C, Chibaudel B, Samson B et al. · The Lancet. Oncology · 2015 · PMID 26474518
- Randomized controlled trial A phase IIa randomized, double-blind trial of erlotinib in inhibiting epidermal growth factor receptor signaling in aberrant crypt foci of the colorectumGillen DL, Meyskens FL, Morgan TR et al. · Cancer prevention research (Philadelphia, Pa.) · 2015 · PMID 25604134
- Cochrane review Epidermal Growth Factor Receptor Mutation (EGFR) Testing for Prediction of Response to EGFR-Targeting Tyrosine Kinase Inhibitor (TKI) Drugs in Patients with Advanced Non-Small-Cell Lung Cancer: An Evidence-Based AnalysisMedical Advisory Secretariat · Ontario health technology assessment series · 2010 · PMID 23074402
- Systematic review Will targeted therapy hold its promise? An evidence-based reviewMurdoch D, Sager J · Current opinion in oncology · 2008 · PMID 18043264
Mechanism and notes
No mechanism of action is recorded for this pair in the source databases.
OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in DGIdb, in this case via the biomarker or target APC. The tier describes how well the drug-disease link is documented, not how well the drug works.
Frequently asked questions
Is Erlotinib approved for Colorectal Cancer?
Erlotinib has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Colorectal Cancer would be drug repurposing rather than first-in-human development. This does not mean it is approved for Colorectal Cancer. Approval status for the specific indication should always be confirmed with the relevant regulator and prescribing information.
Is Erlotinib in clinical trials for Colorectal Cancer?
ClinicalTrials.gov lists 8 registered trials linking Erlotinib to Colorectal Cancer: 6 have completed; 2 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 2 (NCT00032110). The largest enrolment is 43 participants (NCT00397384). Registration activity spans 2002 to 2017.
What does the evidence show for Erlotinib in Colorectal Cancer?
Erlotinib has both completed registered trials and synthesis-level publications linked to Colorectal Cancer. That is the strongest profile in this database, but the summaries here do not extract effect sizes, so read the linked reviews for direction and magnitude of benefit. OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in DGIdb, in this case via the biomarker or target APC. The tier describes how well the drug-disease link is documented, not how well the drug works.
Cite this page
Data: ClinicalTrials.gov, PubMed, Open Targets, ChEMBL, DGIdb and the OSMF therapeutic agent database. Last updated 2026-07-05. Page built 2026-10-07.