Bortezomib in Treating Patients With Metastatic or Recurrent Colorectal Cancer
This study has been completed.
Sponsor:
Princess Margaret Hospital, Canada
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
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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 2 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Study Of PS-341 In Patients With Metastatic Colorectal Cancer |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
| Study Start Date: | January 2003 |
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
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00052507 History of Changes |
| Other Study ID Numbers: | CDR0000258488, PMH-PHL-012, NCI-5890 |
| Study First Received: | January 24, 2003 |
| Last Updated: | July 23, 2008 |
| 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 |
Additional relevant MeSH terms:
|
Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases |
Intestinal Diseases Rectal Diseases Bortezomib Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 23, 2013