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Bortezomib in Treating Patients With Metastatic or Recurrent Colorectal Cancer

Primary Purpose

Colorectal Cancer

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
bortezomib
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring stage IV colon cancer, stage IV rectal cancer, adenocarcinoma of the colon, adenocarcinoma of the rectum, recurrent colon cancer, recurrent rectal cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cancer Care Ontario-Hamilton Regional Cancer Centre
  • Cancer Care Ontario-London Regional Cancer Centre
  • Ottawa Regional Cancer Centre
  • Princess Margaret Hospital at University Health Network

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
January 24, 2003
Last Updated
July 22, 2015
Sponsor
University Health Network, Toronto
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00052507
Brief Title
Bortezomib in Treating Patients With Metastatic or Recurrent Colorectal Cancer
Official Title
A Phase II Study Of PS-341 In Patients With Metastatic Colorectal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
January 2003 (undefined)
Primary Completion Date
August 2005 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
stage IV colon cancer, stage IV rectal cancer, adenocarcinoma of the colon, adenocarcinoma of the rectum, recurrent colon cancer, recurrent rectal cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
bortezomib

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amit M. Oza, MD
Organizational Affiliation
Princess Margaret Hospital, Canada
Official's Role
Study Chair
Facility Information:
Facility Name
Cancer Care Ontario-Hamilton Regional Cancer Centre
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 5C2
Country
Canada
Facility Name
Cancer Care Ontario-London Regional Cancer Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4L6
Country
Canada
Facility Name
Ottawa Regional Cancer Centre
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 1C4
Country
Canada
Facility Name
Princess Margaret Hospital at University Health Network
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
16061869
Citation
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.
Results Reference
result

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Bortezomib in Treating Patients With Metastatic or Recurrent Colorectal Cancer

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