Bortezomib in Treating Patients With Metastatic or Recurrent Colorectal Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00052507
First received: January 24, 2003
Last updated: July 23, 2008
Last verified: December 2003

January 24, 2003
July 23, 2008
January 2003
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Complete list of historical versions of study NCT00052507 on ClinicalTrials.gov Archive Site
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Bortezomib in Treating Patients With Metastatic or Recurrent Colorectal Cancer
A Phase II Study Of PS-341 In Patients With Metastatic Colorectal Cancer

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.

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.

Interventional
Phase 2
Masking: Open Label
Primary Purpose: Treatment
Colorectal Cancer
Drug: bortezomib
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00052507
CDR0000258488, PMH-PHL-012, NCI-5890
Not Provided
Not Provided
Princess Margaret Hospital, Canada
National Cancer Institute (NCI)
Study Chair: Amit M. Oza, MD Princess Margaret Hospital, Canada
National Cancer Institute (NCI)
December 2003

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP