Clinical trial · Interventional
Combination Chemotherapy in Treating Patients With Metastatic Colorectal Cancer
Phase II Trial of O6Benzylguanine and BCNU in Patients With Colon and Rectal Carcinoma
NCT00005981CI-TRIAL-00003527completedPhase 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)
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have 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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| carmustine | Drug | Carmustine | ALIAS |
| O6-benzylguanine | Drug | O6-Benzylguanine | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Determine the response rate of patients with metastatic colorectal carcinoma treated with O6-benzylguanine and carmustine.
- timeFrame
- Treatment continues every 6 weeks in the absence of disease progression or unacceptable toxicity.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of metastatic colorectal carcinoma * Bidimensionally measurable disease PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 Life expectancy: * At least 12 weeks Hematopoietic: * WBC at least 4,000/mm\^3 * Granulocyte count at least 1,500/mm\^3 * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * Hemoglobin greater than 8 g/dL Hepatic: * Bilirubin no greater than 1.2 mg/dL * AST and ALT less than 2.5 times upper limit of normal (ULN) * PT no greater than ULN (not on anticoagulation therapy) Renal: * Creatinine no greater than 1.5 mg/dL * Creatine clearance greater than 60 mL/min Pulmonary: * DLCO at least 60% Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 2 months after study * No other concurrent active malignancies * Prior malignancies presumed to be cured allowed * No other concurrent uncontrolled severe medical problem that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * At least 6 months since prior adjuvant chemotherapy without disease recurrence * No more than 1 prior chemotherapy regimen for metastatic disease Endocrine therapy: * Not specified Radiotherapy: * Prior adjuvant radiotherapy allowed * No prior radiotherapy to more than 25% of total bone marrow Surgery: * Not specified Other: * No other prior therapy for advanced disease
References
Publications (0)
Data not yet available
No reference posted for this study.