NCT00052507

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2003

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

January 24, 2003

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2005

Completed
Last Updated

July 23, 2015

Status Verified

July 1, 2015

Enrollment Period

2.6 years

First QC Date

January 24, 2003

Last Update Submit

July 22, 2015

Conditions

Colorectal Cancer

Keywords

stage IV colon cancerstage IV rectal canceradenocarcinoma of the colonadenocarcinoma of the rectumrecurrent colon cancerrecurrent rectal cancer

Interventions

bortezomibDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (4)

Cancer Care Ontario-Hamilton Regional Cancer Centre

Hamilton, Ontario, L8V 5C2, Canada

Location

Cancer Care Ontario-London Regional Cancer Centre

London, Ontario, N6A 4L6, Canada

Location

Ottawa Regional Cancer Centre

Ottawa, Ontario, K1H 1C4, Canada

Location

Princess Margaret Hospital at University Health Network

Toronto, Ontario, M5G 2M9, Canada

Location

Related Publications (1)

  • 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.

    PMID: 16061869RESULT

MeSH Terms

Conditions

Colorectal NeoplasmsColonic NeoplasmsRectal Neoplasms

Interventions

Bortezomib

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Boronic AcidsAcids, NoncarboxylicAcidsInorganic ChemicalsBoron CompoundsOrganic ChemicalsPyrazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Amit M. Oza, MD

    Princess Margaret Hospital, Canada

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2003

First Posted

January 27, 2003

Study Start

January 1, 2003

Primary Completion

August 1, 2005

Last Updated

July 23, 2015

Record last verified: 2015-07

Locations

CA(4)