SarCNU in Treating Patients With Recurrent or Metastatic Colorectal Cancer

NCIC Clinical Trials Group

Status and phase: Completed; Phase 2

Conditions: Colorectal Cancer

Treatments: Drug: SarCNU

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT00028015

CAN-NCIC-IND146 (Other Identifier)

CDR0000069113 (Other Identifier)

I146

Details and patient eligibility

About

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.

Full 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.

Enrollment: 18 patients

Sex: All

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)