SarCNU in Treating Patients With Recurrent or Metastatic Colorectal Cancer

NCT00028015 | Completed Phase 2 DMC FDA Drug

• 3 other identifiers: I146CAN-NCIC-IND146CDR0000069113
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 7

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.

Conditions

Colorectal Cancer

Keywords

stage IV colon cancer; stage IV rectal cancer; recurrent colon cancer; recurrent rectal cancer

Interventions

SarCNU DRUG

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• NCIC Clinical Trials Group: lead

Study Sites (7)

CancerCare Manitoba

Winnipeg, Manitoba, R3E 0V9, Canada

Location

Kingston Regional Cancer Centre

Kingston, Ontario, K7L 5P9, Canada

Location

Ottawa Regional Cancer Centre

Ottawa, Ontario, K1H 1C4, Canada

Location

Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

Location

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

Hopital Notre- Dame du CHUM

Montreal, Quebec, H2L 4MI, Canada

Location

McGill University

Montreal, Quebec, H2W 1S6, Canada

Location

Related Publications (1)

• Wong 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 RESULT

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Neoplasms; Rectal Neoplasms

Interventions

2-((((2-chloroethyl)nitrosoamino)carbonyl)amino)propanamide

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Ralph PW Wong, MD, FRCPC

  CancerCare Manitoba

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2001
• First Posted: January 27, 2003
• Study Start: October 30, 2001
• Primary Completion: September 22, 2003
• Study Completion: September 22, 2008
• Last Updated: April 9, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (7)