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A Phase II Study of Second-Line SarCNU (NSC 364432) in Patients With Recurrent/Metastatic Colorectal Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Colorectal Cancer

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Trial Information

A Phase II Study of Second-Line SarCNU (NSC 364432) in Patients With Recurrent/Metastatic Colorectal Cancer


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.

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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Ralph P. W. Wong, MD, FRCPC

Investigator Role:

Study Chair

Investigator Affiliation:

CancerCare Manitoba

Authority:

United States: Federal Government

Study ID:

I146

NCT ID:

NCT00028015

Start Date:

October 2001

Completion Date:

Related Keywords:

  • Colorectal Cancer
  • stage IV colon cancer
  • stage IV rectal cancer
  • recurrent colon cancer
  • recurrent rectal cancer
  • Colorectal Neoplasms

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