Clinical trial · Interventional
Optimized Chemotherapy Followed by Maintenance With Bevacizumab With or Without Erlotinib in Treating Patients With Metastatic Colorectal Cancer That Cannot be Removed by Surgery (DREAM)
Phase III Study of an Optimized Chemotherapy Followed by Maintenance With Bevacizumab Strategy With or Without Erlotinib in Unresectable Metastatic Colorectal Cancer. DREAM OPTIMOX 3. C04-2
- 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)
PURPOSE: This randomized phase III trial is studying maintenance therapy with bevacizumab alone after an induction therapy combining bevacizumab+chemotherapy to see how well they work compared to maintenance therapy with bevacizumab+erlotinib alone after an induction therapy combining bevacizumab+chemotherapy in treating patients with metastatic colorectal cancer that cannot be removed by surgery.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bevacizumab | Drug | Bevacizumab | ALIAS |
| bevacizumab, erlotinib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- bevacizumab alone
- interventionNames
- Drug: bevacizumab
- type
- EXPERIMENTAL
- label
- Bevacizumab + erlotinib
- interventionNames
- Drug: bevacizumab, erlotinib
Primary outcomes (1)
- measure
- Progression-free survival during maintenance therapy
- timeFrame
- Tumor evaluation every 2 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
MAIN ELIGIBILITY CRITERIA * Histologically proven metastatic adenocarcinoma of colon or rectum * Documented inoperable disease (i.e., not suitable for complete carcinological surgical resection) * Measurable lesion as assessed by CT scan or MRI in at least one dimension (longest diameter to be recorded) ≥ 20 mm with conventional CT scan or ≥ 10 mm with spiral CT scan * No previous therapy for metastatic disease * No history or evidence upon physical examination of CNS disease (e.g., non-irradiated CNS metastasis, seizure not controlled with standard medical therapy, or history of stroke) unless adequately treated * No exclusive bone metastasis * ECOG performance status 0-2 * WBC ≥ 1,500/mm\^3 * Platelets ≥ 100,000/mm\^3 * Hemoglobin \> 9 g/dL (may be transfused to maintain or exceed this level) * Proteinuria \< 2+ by dipstick OR ≤ 1 g of protein on 24-hr urine collection * Bilirubin \< 1.5 times ULN * Alkaline phosphatase \< 3 times ULN * No peripheral sensory neuropathy * Negative pregnancy test * Fertile patients must use effective means of contraception (oral contraceptives, intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal jelly, or surgically sterilization) * No peripheral neuropathy ≥ grade 1 * No clinically significant (i.e. active) cardiovascular disease * No evidence of bleeding diathesis or coagulopathy * No serious, non-healing wound, ulcer, or bone fracture * No significant ophthalmologic abnormality * More than 28 days since prior major surgical procedure or open biopsy
References
Publications (1)
- DERIVEDTournigand C, Chibaudel B, Samson B, Scheithauer W, Vernerey D, Mesange P, Lledo G, Viret F, Ramee JF, Tubiana-Mathieu N, Dauba J, Dupuis O, Rinaldi Y, Mabro M, Aucoin N, Latreille J, Bonnetain F, Louvet C, Larsen AK, Andre T, de Gramont A. Bevacizumab with or without erlotinib as maintenance therapy in patients with metastatic colorectal cancer (GERCOR DREAM; OPTIMOX3): a randomised, open-label, phase 3 trial. Lancet Oncol. 2015 Nov;16(15):1493-1505. doi: 10.1016/S1470-2045(15)00216-8. Epub 2015 Oct 22. PMID 26474518