Bortezomib in Treating Patients With Metastatic or Recurrent Colorectal Cancer

NCT ID: NCT00052507

Last Updated: 2015-07-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-01-31

Brief 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.

Detailed Description

OBJECTIVES:

• Determine the efficacy of bortezomib, in terms of response rate and stable disease rate, in patients with recurrent or metastatic colorectal cancer.
• Determine the toxicity of this drug in these patients.
• Determine the time to progression and response duration in patients treated with this drug.
• Determine whether there is a relationship between levels of transcription factors NF kappa B and HIF-1 alpha and clinical outcome in patients treated with this drug.

OUTLINE: This is an open-label study.

Patients receive bortezomib IV on days 1, 4, 8, and 11. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 21-41 patients will be accrued for this study within 2-4 months.

Conditions

Colorectal Cancer

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

bortezomib

Intervention Type: DRUG

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Amit M. Oza, MD

Role: STUDY_CHAIR

Princess Margaret Hospital, Canada

Locations

Cancer Care Ontario-Hamilton Regional Cancer Centre

Hamilton, Ontario, Canada

Cancer Care Ontario-London Regional Cancer Centre

London, Ontario, Canada

Ottawa Regional Cancer Centre

Ottawa, Ontario, Canada

Princess Margaret Hospital at University Health Network

Toronto, Ontario, Canada

Countries

Canada

References

Mackay H, Hedley D, Major P, Townsley C, Mackenzie M, Vincent M, Degendorfer P, Tsao MS, Nicklee T, Birle D, Wright J, Siu L, Moore M, Oza A. A phase II trial with pharmacodynamic endpoints of the proteasome inhibitor bortezomib in patients with metastatic colorectal cancer. Clin Cancer Res. 2005 Aug 1;11(15):5526-33. doi: 10.1158/1078-0432.CCR-05-0081.

Reference Type: RESULT

PMID: 16061869 (View on PubMed)

Other Identifiers

CDR0000258488

Identifier Type: REGISTRY

Identifier Source: secondary_id

NCI-5890

Identifier Type: -

Identifier Source: secondary_id

PMH-PHL-012

Identifier Type: -

Identifier Source: org_study_id