Clinical trial · Interventional
Study of Oxaliplatin, Capecitabine, and Bevacizumab to Treat Older Patients With Colorectal Cancer
A Phase II Study of Oxaliplatin, Capecitabine, and Bevacizumab in the Treatment of Elderly Patients With Metastatic Colorectal Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): positive results from a larger study with same regimen was released.
Summary
Brief summary (as posted)
Currently there is no one standard of care for older patients with metastatic colorectal cancer. The study will examine the tumor response to capecitabine, oxaliplatin, plus bevacizumab. The study will also gather information on the usefulness and side effects of this treatment combination.
Conditions
Conditions (2)
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 |
| Neoplasm Metastasis | Colorectal Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| oxaliplatin, capecitabine, bevacizumab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- To evaluate the efficacy (measured by time to progression) of oxaliplatin, capecitabine, and bevacizumab as first-line therapy in elderly patients with metastatic colorectal cancer.
Secondary outcomes (4)
- measure
- Overall response
- measure
- Duration of response
- measure
- Safety and tolerability (NCI CTCAE v3.0, discontinuations, dose intensity)
- measure
- Vulnerable Elders Survey (VES-13) and Geriatric Depression Scale (GDS) scores
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Age 65 years and above; * Histologically or cytologically documented adenocarcinoma of the colon or rectum; * Metastatic disease; * Measurable disease or assessable but nonmeasurable disease allowed; * ECOG 0-1 * No prior oxaliplatin or bevacizumab. * No prior chemotherapy for metastatic disease. Prior adjuvant chemotherapy allowed; * No prior fluoropyrimidine therapy (unless give in an adjuvant setting and completed at least 4 months earlier); * No bleeding diathesis or coagulopathy * Adequate renal and hepatic functions as per protocol; * Signed informed consent Exclusion Criteria: * Clinically significant cardiovascular or peripheral vascular disease; * Concurrent chronic aspirin, nonsteroidal anti-inflammatory drugs, warfarin, or therapeutic heparin; * Serious non-healing wound, ulcer, or bone fracture;
References
Publications (0)
Data not yet available