Clinical trial · Interventional
Capecitabine and Thalidomide in Previously Treated Metastatic Colorectal Carcinoma
A Phase II Trial of Capecitabine and Thalidomide in Previously Treated Metastatic Colorectal Carcinoma
NCT00165217CI-TRIAL-00001040completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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)
The purpose of this study is to collect information about the antitumor activity and the safety of capecitabine and thalidomide in patients with 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 Adenocarcinoma | Colorectal Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capecitabine | Drug | Capecitabine | ALIAS |
| Thalidomide | Drug | Thalidomide | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- To assess the anti-tumor activity of capecitabine and thalidomide when administered to patients with previously treated metastatic colorectal cancer.
Secondary outcomes (1)
- measure
- To evaluate the safety of capecitabine and thalidomide in this patient population.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologic proof of colorectal adenocarcinoma with radiological or cytological evidence of stage IV (metastatic) disease * Measurable tumor * Serum creatinine \< 1.5 mg/dl * Total bilirubin \< 2.0 mg/dl * AST \< 5 x ULN * ANC \> 1,500/mm3 * Platelets \> 100,000/mm3 * Hemoglobin \> 9.0 gm/dl * Must have received at least one prior chemotherapy regimen for metastatic colorectal cancer. At least 3 weeks must have passed since the last chemotherapy treatment * 18 years of age or older * ECOG performance status of less than or equal to 2 * Life expectancy of greater than 12 weeks Exclusion Criteria: * Prior treatment with mitomycin C or nitrosourea compounds * Prior treatment with capecitabine or thalidomide * Clinically apparent central nervous system metastases or carcinomatous meningitis * Peripheral neuropathy of grade 2 or greater severity * Myocardial infarction in the past 6 months * Major surgery in the past 2 weeks * Uncontrolled serious medical or psychiatric illness * Pregnant or lactating women * Concurrent malignancy of any site, except limited basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the cervix. * Known allergy to 5-FU
References
Publications (0)
Data not yet available
No reference posted for this study.