Clinical trial · Interventional
Erlotinib, Modified FOLFOX6, and Bevacizumab as First-Line Therapy Metastatic Colorectal Cancer
A Phase IB Study in Patients With Metastatic Colorectal Cancer to Evaluate Pharmacodynamic Effects of Erlotinib and Safety and Efficacy of Erlotinib in Combination With Modified FOLFOX6 (mFOLFOX6) and Bevacizumab
- 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: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as oxaliplatin, leucovorin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Erlotinib may help chemotherapy work better by making tumor cells more sensitive to the drugs. Giving erlotinib together with combination chemotherapy and bevacizumab may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of erlotinib when given together with combination chemotherapy and bevacizumab as first-line therapy in treating patients with 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 |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bevacizumab | Biological | Bevacizumab | ALIAS |
| erlotinib hydrochloride | Drug | Erlotinib Hydrochloride | ALIAS |
| fluorouracil | Drug | Fluorouracil | ALIAS |
| leucovorin calcium | Drug | Leucovorin | ALIAS |
| oxaliplatin | Drug | Oxaliplatin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Erlotinib, modified FOLFOX6, and bevacizumab
- interventionNames
- Biological: bevacizumab
- Drug: erlotinib hydrochloride
- Drug: fluorouracil
- Drug: leucovorin calcium
- Drug: oxaliplatin
Primary outcomes (1)
- measure
- Number of patients that develop study drug related toxicity
- timeFrame
- 3 courses (6 weeks)
- description
- Dose-limiting toxicities will be tracked in the first three cycles. The occurrence of DLT in 2 of the first 6 patients, 3 of the first 9 patients, or 4 of the first 12 patients (whichever occurs soonest)will require that subsequent patients are enrolled to the study at 100 mg erlotinib daily.
Secondary outcomes (2)
- measure
- Patient Response to Treatment Measured by RECIST Criteria
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed colorectal cancer * Biopsy-accessible metastatic disease * Measurable disease * No CNS metastases PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-2 Life expectancy * At least 3 months Hematopoietic * WBC ≥ 4,000/mm\^3 OR * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Hemoglobin ≥ 10 g/dL * No bleeding disorder Hepatic * Bilirubin ≤ 1.5 mg/dL * Albumin ≥ 2.5 g/dL Renal * Creatinine ≤ 1.5 mg/dL * Urine protein:creatine ratio \< 1.0 Cardiovascular * Blood pressure ≤ 150/100 mmHg * No arterial thrombotic event within the past 6 months * No New York Heart Association grade II-IV congestive heart failure Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 1 month after completion of study treatment * No other malignancy within the past 3 years except nonmelanoma skin cancer, carcinoma in situ of the cervix, or other malignancy with \< 10% chance of relapse within 3 years * No uncontrolled infection * No severe uncontrolled illness that would preclude study participation * No peripheral neuropathy interfering with function * No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months * No serious non-healing wound, ulcer, or bone fracture PRIOR CONCURRENT THERAPY: Biologic therapy * No concurrent immunotherapy * No concurrent sargramostim (GM-CSF) Chemotherapy * No prior chemotherapy, including oxaliplatin, for metastatic disease * Prior adjuvant oxaliplatin allowed provided disease progressed \> 12 months after completion of oxaliplatin * At least 3 weeks since prior cytotoxic chemotherapy (6 weeks for mitomycin or nitrosoureas) * No more than 2 courses of prior mitomycin * No concurrent chemotherapy Endocrine therapy * No concurrent anticancer hormonal therapy Radiotherapy * At least 2 weeks since prior radiotherapy * No prior radiotherapy to \> 15% of bone marrow * No concurrent radiotherapy Surgery * At least 4 weeks since prior major surgery * At least 1 week since prior minor surgery Other * Recovered from prior therapy * No prior epidermal growth factor receptor inhibitor therapy * No other concurrent antineoplastic or antitumor therapy * No other concurrent investigational agents
References
Publications (0)
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