Bortezomib in Treating Patients With Metastatic or Recurrent Colorectal Cancer

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Bortezomib may interfere with the growth of tumor cells by blocking the enzymes necessary for cancer cell growth.

PURPOSE: Phase II trial to study the effectiveness of bortezomib in treating patients who have metastatic or recurrent colorectal cancer.

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

Details

• Lead Sponsor: University Health Network, Toronto
• Collaborator: National Cancer Institute (NCI)
• Treatments: Bortezomib

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed adenocarcinoma of the colon or rectum that is incurable with conventional therapy

• Metastatic or recurrent disease

• At least 1 unidimensionally measurable lesion

• At least 20 mm by conventional techniques or at least 10 mm by spiral CT scan

• Disease must be accessible to biopsy

• No known brain metastases

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• ECOG 0-1 OR

• Karnofsky 70-100%

Life expectancy

• More than 3 months

Hematopoietic

• Absolute granulocyte count at least 1,500/mm^3

• WBC at least 3,000/mm^3

• Platelet count at least 100,000/mm^3

Hepatic

• Bilirubin no greater than 1.25 times upper limit of normal (ULN)

• AST or ALT no greater than 3 times ULN (less than 5 times ULN if liver metastases present)

Renal

• Creatinine no greater than 1.25 times UNL OR

• Creatinine clearance at least 50 mL/min

Cardiovascular

• No symptomatic congestive heart failure

• No unstable angina pectoris

• No cardiac arrhythmia

Other

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No psychiatric illness or social situation that would preclude study compliance

• No other uncontrolled concurrent illness

• No ongoing or active infection

• No other active malignancy within the past 3 years except curatively treated nonmelanoma skin cancer or carcinoma in situ of the cervix

• No grade 1 or greater peripheral neuropathy due to prior chemotherapy

• No significant traumatic injury within the past 21 days

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• No more than 1 line of prior chemotherapy (including any combination of fluorouracil, irinotecan, and/or oxaliplatin) for metastatic disease

• At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered

• Prior adjuvant chemotherapy allowed

• No concurrent cytotoxic chemotherapy

Radiotherapy

• More than 4 weeks since prior radiotherapy and recovered

• No prior radiotherapy to measurable target lesion unless disease progression has occurred after radiotherapy

• No concurrent radiotherapy to the sole site of measurable disease

Surgery

• More than 21 days since prior major surgery

Other

• No other concurrent investigational agents

• No concurrent combination antiretroviral therapy for HIV-positive patients