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SarCNU in Treating Patients With Recurrent or Metastatic Colorectal Cancer
This study has been completed.
First Received: December 7, 2001   Last Updated: July 23, 2008   History of Changes
Sponsored by: National Cancer Institute of Canada
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00028015
  Purpose

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.


Condition Intervention Phase
Colorectal Cancer
Drug: SarCNU
Phase II

Study Type: Interventional
Study Design: Treatment
Official Title: A Phase II Study of Second-Line SarCNU (NSC 364432) in Patients With Recurrent/Metastatic Colorectal Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: October 2001
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00028015

Locations
Canada, Manitoba
CancerCare Manitoba
Winnipeg, Manitoba, Canada, R3E 0V9
Canada, Ontario
Kingston Regional Cancer Centre
Kingston, Ontario, Canada, K7L 5P9
Ottawa Regional Cancer Centre
Ottawa, Ontario, Canada, K1H 1C4
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Toronto General Hospital
Toronto, Ontario, Canada, M5G 2C4
Canada, Quebec
Hopital Notre- Dame du CHUM
Montreal, Quebec, Canada, H2L 4MI
McGill University
Montreal, Quebec, Canada, H2W 1S6
Sponsors and Collaborators
National Cancer Institute of Canada
Investigators
Study Chair: Ralph P. W. Wong, MD, FRCPC CancerCare Manitoba
  More Information

Additional Information:
Publications:
Study ID Numbers: CDR0000069113, CAN-NCIC-IND146, NCI-NCIC-146
Study First Received: December 7, 2001
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00028015     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IV colon cancer
stage IV rectal cancer
recurrent colon cancer
recurrent rectal cancer

Study placed in the following topic categories:
Digestive System Neoplasms
Rectal Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Rectal Neoplasm
Intestinal Diseases
Rectal Diseases
Recurrence
Intestinal Neoplasms
Digestive System Diseases
Rectal Cancer
Gastrointestinal Neoplasms
Colorectal Neoplasms
2-((((2-chloroethyl)nitrosoamino)carbonyl)amino)propanamide

Additional relevant MeSH terms:
Digestive System Neoplasms
Gastrointestinal Diseases
Antineoplastic Agents
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Pharmacologic Actions
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Digestive System Diseases
Therapeutic Uses
Gastrointestinal Neoplasms
Colorectal Neoplasms
2-((((2-chloroethyl)nitrosoamino)carbonyl)amino)propanamide

ClinicalTrials.gov processed this record on July 02, 2009