ISIS 2503 in Treating Patients With Metastatic and/or Locally Recurrent Colorectal Cancer
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Purpose
RATIONALE: ISIS 2503 may kill cancer cells by inhibiting a gene that promotes the development and growth of cancer.
PURPOSE: Phase II trial to study the effectiveness of ISIS 2503 in treating patients who have metastatic and/or locally recurrent colorectal cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Colorectal Cancer |
Drug: ISIS 2503 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Trial of ISIS 2503, an Antisense Inhibitor of H-ras, in Patients With Advanced Colorectal Cancer |
- Determine the response rate, duration of response, and time to progression in patients with metastatic and/or locally recurrent adenocarcinoma of the colon or rectum treated with ISIS 2503, an antisense inhibitor of H-ras [ Time Frame: baseline to survival ] [ Designated as safety issue: No ]
- Determine the safety profile of this regimen in these patients. [ Time Frame: Baseline to 1 year ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 25 |
| Study Start Date: | January 1999 |
| Study Completion Date: | November 2000 |
| Primary Completion Date: | November 2000 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: ISIS 2503
patients who have metastatic and/or locally recurrent colorectal cancer
|
Drug: ISIS 2503 |
Detailed Description:
OBJECTIVES: I. Determine the response rate, duration of response, and time to progression in patients with metastatic and/or locally recurrent adenocarcinoma of the colon or rectum treated with ISIS 2503, an antisense inhibitor of H-ras. II. Determine the safety profile of this regimen in these patients.
OUTLINE: This is a multicenter study. Patients receive ISIS 2503 IV continuously for 14 days. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 14-25 patients will be accrued for this study within 1 year.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histologically proven metastatic and/or locally recurrent adenocarcinoma of the colon or rectum that is not expected to be cured with standard therapy Patients who previously underwent definitive surgical resection and subsequently develop metastatic disease should have diagnosis reconfirmed with new histologic or cytologic specimen if: More than 5 years have elapsed since primary surgery OR Primary tumor was stage I or II At least 1 measurable lesion (2 cm or more in widest diameter) by CT or MRI scan No CNS metastases
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0 or 1 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count greater than 1,500/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL Renal: Creatinine no greater than 1.5 mg/dl Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 6 months after study No underlying disease state associated with active bleeding No active infection requiring therapy No second malignancy within the past 5 years except curatively treated nonmelanomatous skin cancer
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy for metastatic disease At least 6 months since prior adjuvant chemotherapy with or without radiotherapy Endocrine therapy: Not specified Radiotherapy: Prior radiotherapy to nonindicator lesion allowed and recovered See Chemotherapy Surgery: See Disease Characteristics Other: No concurrent approved cancer therapy or other experimental therapy
Contacts and Locations| United States, Alabama | |
| University of Alabama Comprehensive Cancer Center | |
| Birmingham, Alabama, United States, 35294 | |
| Study Chair: | Mansoor N. Saleh, MD | University of Alabama at Birmingham |
More Information
Additional Information:
No publications provided
| Responsible Party: | University of Alabama at Birmingham |
| ClinicalTrials.gov Identifier: | NCT00004193 History of Changes |
| Other Study ID Numbers: | CDR0000067434, UAB-9860, ISIS-2503-CS6, NCI-G99-1649 |
| Study First Received: | January 21, 2000 |
| Last Updated: | April 10, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by University of Alabama at Birmingham:
|
stage IV colon cancer stage IV rectal cancer recurrent colon cancer |
recurrent rectal cancer adenocarcinoma of the colon adenocarcinoma of the rectum |
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 |
ClinicalTrials.gov processed this record on May 19, 2013