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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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00028015
Enrollment
18
Registered
2003-01-27
Start date
2001-10-30
Completion date
2008-09-22
Last updated
2020-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer

Keywords

stage IV colon cancer, stage IV rectal cancer, recurrent colon cancer, recurrent rectal cancer

Brief summary

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.

Detailed description

OBJECTIVES: * Determine the efficacy of SarCNU in patients with recurrent or metastatic colorectal cancer. * Determine the qualitative and quantitative toxicity of this drug in these patients. * Determine the time to progression and survival of patients treated with this drug. OUTLINE: This is a multicenter study. Patients receive oral SarCNU on days 1, 5, and 9. Treatment repeats every 6 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response (CR) receive 2 additional courses beyond documentation of CR. Patients who achieve partial response (PR) receive 4 additional courses beyond documentation of PR. Patients are followed at 4 weeks and then every 3 months thereafter. PROJECTED ACCRUAL: A total of 15-30 patients will be accrued for this study within 6-8 months.

Interventions

DRUGSarCNU

Sponsors

NCIC Clinical Trials Group
Lead SponsorNETWORK

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No

Inclusion criteria

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

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026