Clinical trial · Interventional
Surgery With or Without Thalidomide in Treating Patients With Recurrent or Metastatic Colorectal Cancer
A Phase II Trial of Oral Thalidomide as an Adjuvant Agent Following Metastasectomy in Patients With Recurrent Colorectal Cancer
NCT00019747CI-TRIAL-00019631terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): DSMB recommended closure of the protocol due to slow accrual.
Summary
Brief summary (as posted)
RATIONALE: Thalidomide may stop the growth of colorectal cancer by stopping blood flow to the tumor. Giving thalidomide after surgery may kill any remaining tumor cells. PURPOSE: This randomized phase II trial is studying surgery and thalidomide to see how well they work compared to surgery alone in treating patients with recurrent or 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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| adjuvant therapy | Procedure | — | UNRESOLVED |
| Placebo | Other | — | UNRESOLVED |
| thalidomide | Drug | Thalidomide | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm 1 - Thalidomide once daily
- description
- Patients receive oral thalidomide 100 mg at bedtime once daily for 4 weeks, then progresses to 200 mg at bedtime for 4 weeks, then progresses to 300 mg at bedtime (maintenance dose).
- interventionNames
- Drug: thalidomide
- Procedure: adjuvant therapy
- type
- PLACEBO_COMPARATOR
- label
- Arm 2 - Placebo once daily
- description
- Patients receive oral placebo once daily.
- interventionNames
- Procedure: adjuvant therapy
- Other: Placebo
Primary outcomes (1)
- measure
- Time to Progression
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of recurrent or metastatic colorectal carcinoma previously resected within 12 weeks of study entry * Surgical resection combined with radiofrequency ablation allowed PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Not specified Life expectancy: * Not specified Hematopoietic: * Hemoglobin at least 8.0 g/dL * Absolute neutrophil count at least 1,000/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Partial thromboplastin time (PTT)/prothrombin time (PT) no greater than 120% of control (except in therapeutically anticoagulated nonrelated medical conditions \[e.g., atrial fibrillation\]) * Total bilirubin no greater than 2.0 mg/dL (direct bilirubin no greater than 1.0 mg/dL for patients with Gilbert's syndrome) * Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) less than 2.5 times normal * No history of hepatic cirrhosis * No concurrent hepatic dysfunction Renal: * Creatinine no greater than 2.0 mg/dL Cardiovascular: * No severe congestive heart failure or active ischemic heart disease * No active clots within 1 year before diagnosis OR must be receiving concurrent treatment with anticoagulant (e.g., low molecular weight heparin or equivalent agent) Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use 1 highly effective method of contraception AND 1 additional effective method of contraception for least 4 weeks before, during, and for at least 4 weeks after study participation * No history of severe hypothyroidism * No history of seizures * No significant history of other medical problems that would preclude surgery * No peripheral neuropathy greater than grade 1, except localized neuropathy due to a mechanical cause or trauma PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 4 weeks since prior biologic therapy Chemotherapy: * At least 4 weeks since prior chemotherapy Endocrine therapy: * Not specified Radiotherapy: * At least 4 weeks since prior radiotherapy Surgery: * See Disease Characteristics Other: * See Cardiovascular * No concurrent sedating drugs that cannot be reduced to a minimal level * No concurrent sedating recreational drugs or alcohol * No concurrent antiseizure medications
References
Publications (0)
Data not yet available
No reference posted for this study.