search
Back to results

Olimersen and Irinotecan in Treating Patients With Metastatic or Recurrent Colorectal Cancer

Primary Purpose

Colorectal Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
oblimersen sodium
irinotecan hydrochloride
Sponsored by
The University of Texas Health Science Center at San Antonio
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, recurrent colon cancer, recurrent rectal cancer, adenocarcinoma of the colon, adenocarcinoma of the rectum

Eligibility Criteria

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

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed unresectable metastatic or recurrent adenocarcinoma of the colon or rectum No brain metastases unless previously treated, asymptomatic, on stable dose of decadron, and CT/MRI scan demonstrates no evidence of edema Phase I: Measurable or evaluable disease Phase II: Measurable disease Evidence of +1 bcl-2 expression on immunohistochemical staining in pathologic material PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: Platelet count at least 100,000/mm3 Hemoglobin at least 9.0 g/dL Absolute granulocyte count at least 1,500/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL AST/ALT no greater than 3 times upper limit of normal (ULN) (5 times ULN if liver metastases) PT/PTT normal Renal: Creatinine no greater than 1.5 mg/dL Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No active infection No serious concurrent systemic disorders that would preclude study treatment PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent immunotherapy Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas and mitomycin) and recovered No other concurrent chemotherapy Phase I: At least 4 weeks since prior irinotecan and recovered Phase II: No more than 2 prior fluorouracil-based regimens for metastatic disease No prior irinotecan Endocrine therapy: See Disease Characteristics No concurrent anticancer hormonal therapy Radiotherapy: No concurrent radiotherapy Surgery: See Disease Characteristics Other: No other concurrent experimental medications

Sites / Locations

  • Ireland Cancer Center
  • Brooke Army Medical Center
  • San Antonio Cancer Institute

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
March 7, 2000
Last Updated
February 19, 2013
Sponsor
The University of Texas Health Science Center at San Antonio
Collaborators
National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT00004870
Brief Title
Olimersen and Irinotecan in Treating Patients With Metastatic or Recurrent Colorectal Cancer
Official Title
A Phase I/II, Pharmacokinetic, and Biologic Correlative Study of G3139, NSC # 683428 (Phosphorothioate Antisense Oligonucleotide Directed to Bcl-2) and Irinotecan in Patients With Metastatic Colorectal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
June 2000 (undefined)
Primary Completion Date
September 2002 (Actual)
Study Completion Date
September 2002 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Texas Health Science Center at San Antonio
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Gene therapy such as oblimersen may make tumor cells more sensitive to chemotherapy drugs. Combining irinotecan and oblimersen may kill more tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of combining oblimersen and irinotecan in treating patients who have metastatic or recurrent colorectal cancer.
Detailed Description
OBJECTIVES: I. Determine the dose-limiting toxic effects and maximum tolerated dose of augmerosen (G3139) administered in combination with irinotecan in patients with unresectable metastatic or recurrent colorectal cancer. II. Determine the quantitative and qualitative toxicity of this drug combination in this patient population. III. Assess the plasma pharmacokinetics of this combination in these patients. IV. Document the antitumor activity of this drug combination in these patients in a phase II study. V. Determine the relevant biologic endpoints of treatment in tumor biopsies prior to and after therapy with G3139 at two dose levels and assess the pharmacokinetic and pharmacodynamic correlations. OUTLINE: This is a dose-escalation, multicenter study. Patients receive augmerosen (G3139) IV continuously on days 1-7 and irinotecan IV over 90 minutes on day 6. Treatment continues every 21 days in the absence of unacceptable toxicity or disease progression. Cohorts of 3-6 patients receive escalating doses of G3139 and irinotecan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, additional patients are accrued to receive treatment with G3139 and irinotecan at the recommended phase II dose. Patients are followed every 30 days until toxicity resolves. PROJECTED ACCRUAL: A maximum of 18 patients will be accrued for the phase I portion of this study. A maximum of 55 patients will be accrued for the phase II portion of this study.

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, recurrent colon cancer, recurrent rectal cancer, adenocarcinoma of the colon, adenocarcinoma of the rectum

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
oblimersen sodium
Intervention Type
Drug
Intervention Name(s)
irinotecan hydrochloride

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed unresectable metastatic or recurrent adenocarcinoma of the colon or rectum No brain metastases unless previously treated, asymptomatic, on stable dose of decadron, and CT/MRI scan demonstrates no evidence of edema Phase I: Measurable or evaluable disease Phase II: Measurable disease Evidence of +1 bcl-2 expression on immunohistochemical staining in pathologic material PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: Platelet count at least 100,000/mm3 Hemoglobin at least 9.0 g/dL Absolute granulocyte count at least 1,500/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL AST/ALT no greater than 3 times upper limit of normal (ULN) (5 times ULN if liver metastases) PT/PTT normal Renal: Creatinine no greater than 1.5 mg/dL Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No active infection No serious concurrent systemic disorders that would preclude study treatment PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent immunotherapy Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas and mitomycin) and recovered No other concurrent chemotherapy Phase I: At least 4 weeks since prior irinotecan and recovered Phase II: No more than 2 prior fluorouracil-based regimens for metastatic disease No prior irinotecan Endocrine therapy: See Disease Characteristics No concurrent anticancer hormonal therapy Radiotherapy: No concurrent radiotherapy Surgery: See Disease Characteristics Other: No other concurrent experimental medications
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anthony W. Tolcher, MD
Organizational Affiliation
San Antonio Cancer Institute
Official's Role
Study Chair
Facility Information:
Facility Name
Ireland Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106-5065
Country
United States
Facility Name
Brooke Army Medical Center
City
Fort Sam Houston
State/Province
Texas
ZIP/Postal Code
78234
Country
United States
Facility Name
San Antonio Cancer Institute
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Olimersen and Irinotecan in Treating Patients With Metastatic or Recurrent Colorectal Cancer

We'll reach out to this number within 24 hrs