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SarCNU in Treating Patients With Recurrent or Metastatic Colorectal Cancer

Primary Purpose

Colorectal Cancer

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
SarCNU
Sponsored by
NCIC Clinical Trials Group
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring stage IV colon cancer, stage IV rectal cancer, recurrent colon cancer, recurrent rectal cancer

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CancerCare Manitoba
  • Kingston Regional Cancer Centre
  • Ottawa Regional Cancer Centre
  • Toronto General Hospital
  • Princess Margaret Hospital
  • Hopital Notre- Dame du CHUM
  • McGill University

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
December 7, 2001
Last Updated
April 7, 2020
Sponsor
NCIC Clinical Trials Group
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1. Study Identification

Unique Protocol Identification Number
NCT00028015
Brief Title
SarCNU in Treating Patients With Recurrent or Metastatic Colorectal Cancer
Official Title
A Phase II Study of Second-Line SarCNU (NSC 364432) in Patients With Recurrent/Metastatic Colorectal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
October 30, 2001 (Actual)
Primary Completion Date
September 22, 2003 (Actual)
Study Completion Date
September 22, 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NCIC Clinical Trials Group

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
stage IV colon cancer, stage IV rectal cancer, recurrent colon cancer, recurrent rectal cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
SarCNU

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ralph PW Wong, MD, FRCPC
Organizational Affiliation
CancerCare Manitoba
Official's Role
Study Chair
Facility Information:
Facility Name
CancerCare Manitoba
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 0V9
Country
Canada
Facility Name
Kingston Regional Cancer Centre
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 5P9
Country
Canada
Facility Name
Ottawa Regional Cancer Centre
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 1C4
Country
Canada
Facility Name
Toronto General Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada
Facility Name
Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Hopital Notre- Dame du CHUM
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 4MI
Country
Canada
Facility Name
McGill University
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2W 1S6
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
16502354
Citation
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.
Results Reference
result

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SarCNU in Treating Patients With Recurrent or Metastatic Colorectal Cancer

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