Clinical trial · Interventional
SarCNU in Treating Patients With Recurrent or Metastatic Colorectal Cancer
A Phase II Study of Second-Line SarCNU (NSC 364432) in Patients With Recurrent/Metastatic Colorectal Cancer
NCT00028015CI-TRIAL-00044565completedPhase 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. PURPOSE: Phase II trial to study the effectiveness of sarCNU in treating patients who have 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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SarCNU | Drug | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed colorectal cancer * Locally recurrent or metastatic disease * Previously treated with 1 chemotherapy regimen for recurrent or metastatic disease * At least 1 unidimensionally measurable lesion * At least 20 mm by conventional techniques OR * At least 10 mm by spiral CT scan * No prior radiotherapy to indicator lesion (clear disease progression or new lesion within a prior radiation port is acceptable) PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 Life expectancy: * Not specified Hematopoietic: * Absolute granulocyte count at least 1,500/mm\^3 * Platelet count at least 120,000/mm\^3 Hepatic: * Bilirubin normal * AST and ALT no greater than 2.5 times upper limit of normal Renal: * Creatinine normal OR * Creatinine clearance at least 60 mL/min Cardiovascular: * No symptomatic congestive heart failure * No unstable angina pectoris * No cardiac arrhythmia Pulmonary: * DLCO at least 80% predicted * FVC at least 80% predicted * No history of significant pulmonary disease * No concurrent symptomatic pulmonary disease (e.g., chronic obstructive pulmonary disorder, chronic asthma) Other: * No other malignancy within the past 5 years except adequately treated nonmelanoma skin cancer or curatively treated carcinoma in situ of the cervix * No other serious illness or medical condition that would preclude study * No ongoing or active uncontrolled infection * No history of significant neurologic or psychiatric disorder that would preclude study * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 3 months after study PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 4 weeks since prior immunotherapy * No concurrent immunotherapy Chemotherapy: * See Disease Characteristics * Prior adjuvant chemotherapy allowed * No prior nitrosoureas * No prior second-line chemotherapy for recurrent or metastatic disease * At least 4 weeks since prior chemotherapy * No other concurrent chemotherapy Endocrine therapy: * No concurrent corticosteroids Radiotherapy: * See Disease Characteristics * Prior radiotherapy as part of primary therapy allowed * At least 4 weeks since prior radiotherapy * No concurrent radiotherapy Surgery: * Prior surgery as part of primary therapy allowed * Prior reoperation for recurrent disease allowed * At least 2 weeks since prior surgery other than biopsy Other: * At least 4 weeks since prior investigational agent * No other concurrent investigational agents or therapy * No other concurrent anticancer therapy
References
Publications (1)
- RESULTWong RP, Baetz T, Krahn MJ, Biagi J, Wainman N, Eisenhauer E; National Cancer Institute of Canada Clinical Trials Group. SarCNU in recurrent or metastatic colorectal cancer: a phase II study of the National Cancer Institute of Canada Clinical Trials Group. Invest New Drugs. 2006 Jul;24(4):347-51. doi: 10.1007/s10637-006-5730-2. PMID 16502354