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Bortezomib in Treating Patients With Metastatic or Recurrent Colorectal Cancer
This study has been completed.
Sponsors and Collaborators: Princess Margaret Hospital, Canada
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00052507
  Purpose

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.


Condition Intervention Phase
Colorectal Cancer
Drug: bortezomib
Phase II

MedlinePlus related topics: Cancer Colorectal Cancer
Drug Information available for: Bortezomib
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: A Phase II Study Of PS-341 In Patients With Metastatic Colorectal Cancer

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: January 2003
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00052507

Locations
Canada, Ontario
Cancer Care Ontario-Hamilton Regional Cancer Centre
Hamilton, Ontario, Canada, L8V 5C2
Cancer Care Ontario-London Regional Cancer Centre
London, Ontario, Canada, N6A 4L6
Ottawa Regional Cancer Centre
Ottawa, Ontario, Canada, K1H 1C4
Princess Margaret Hospital at University Health Network
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
Princess Margaret Hospital, Canada
Investigators
Study Chair: Amit M. Oza, MD Princess Margaret Hospital, Canada
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Publications of Results:
Study ID Numbers: CDR0000258488, PMH-PHL-012, NCI-5890
Study First Received: January 24, 2003
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00052507  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IV colon cancer
stage IV rectal cancer
adenocarcinoma of the colon
adenocarcinoma of the rectum
recurrent colon cancer
recurrent rectal cancer

Study placed in the following topic categories:
Digestive System Neoplasms
Rectal Neoplasms
Gastrointestinal Diseases
Bortezomib
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Recurrence
Intestinal Neoplasms
Rectal neoplasm
Digestive System Diseases
Gastrointestinal Neoplasms
Adenocarcinoma
Rectal cancer
Colorectal Neoplasms

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Pharmacologic Actions
Protease Inhibitors

ClinicalTrials.gov processed this record on January 16, 2009