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

This study has been completed.
National Cancer Institute (NCI)
Information provided by (Responsible Party):
The University of Texas Health Science Center at San Antonio Identifier:
First received: March 7, 2000
Last updated: February 19, 2013
Last verified: February 2013

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.

Condition Intervention Phase
Colorectal Cancer
Biological: oblimersen sodium
Drug: irinotecan hydrochloride
Phase 1
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by The University of Texas Health Science Center at San Antonio:

Study Start Date: June 2000
Study Completion Date: September 2002
Primary Completion Date: September 2002 (Final data collection date for primary outcome measure)
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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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Please refer to this study by its identifier: NCT00004870

United States, Ohio
Ireland Cancer Center
Cleveland, Ohio, United States, 44106-5065
United States, Texas
Brooke Army Medical Center
Fort Sam Houston, Texas, United States, 78234
San Antonio Cancer Institute
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
The University of Texas Health Science Center at San Antonio
National Cancer Institute (NCI)
Study Chair: Anthony W. Tolcher, MD San Antonio Cancer Institute
  More Information

Responsible Party: The University of Texas Health Science Center at San Antonio Identifier: NCT00004870     History of Changes
Other Study ID Numbers: CDR0000067529
Study First Received: March 7, 2000
Last Updated: February 19, 2013

Keywords provided by The University of Texas Health Science Center at San Antonio:
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
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on April 28, 2017