SarCNU in Treating Patients With Recurrent or Metastatic Colorectal Cancer

• Status: Completed
• Trial end date: 2008-09-22
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NCIC Clinical Trials Group
• Treatments: 2-((((2-chloroethyl)nitrosoamino)carbonyl)amino)propanamide

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