SarCNU in Treating Patients With Recurrent or Metastatic Colorectal Cancer

NCT ID: NCT00028015

Last Updated: 2020-04-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-10-30
• Study Completion Date: 2008-09-22

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.

Conditions

Colorectal Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

SarCNU

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NCIC Clinical Trials Group

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ralph PW Wong, MD, FRCPC

Role: STUDY_CHAIR

CancerCare Manitoba

Locations

CancerCare Manitoba

Winnipeg, Manitoba, Canada

Kingston Regional Cancer Centre

Kingston, Ontario, Canada

Ottawa Regional Cancer Centre

Ottawa, Ontario, Canada

Toronto General Hospital

Toronto, Ontario, Canada

Princess Margaret Hospital

Toronto, Ontario, Canada

Hopital Notre- Dame du CHUM

Montreal, Quebec, Canada

McGill University

Montreal, Quebec, Canada

Countries

Canada

References

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.

Reference Type: RESULT

PMID: 16502354 (View on PubMed)

Other Identifiers

CAN-NCIC-IND146

Identifier Type: OTHER

Identifier Source: secondary_id

CDR0000069113

Identifier Type: OTHER

Identifier Source: secondary_id

I146

Identifier Type: -

Identifier Source: org_study_id