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Home > "G" Clinical Trials Conditions > G3139 and Irinotecan in Treating Patients With Metastatic or Recurrent Colorectal Cancer  G3139 and Irinotecan in Treating Patients With Metastatic or Recurrent Colorectal Cancer
G3139 and Irinotecan in Treating Patients With Metastatic or Recurrent Colorectal Cancer
For Condition: recurrent colon cancer,Stage 4 rectal cancer,stage 4 colon cancer,adenocarcinoma of the colon,recurrent rectal cancer,adenocarcinoma of the rectum
Status: Completed
Sponsor(s): National Cancer Institute (NCI) , San Antonio Cancer Institute
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Gene therapy such as bcl-2 antisense oligodeoxynucleotide G3139 (G3139) may make tumor cells more sensitive to chemotherapy drugs. Combining irinotecan and G3139 may kill more tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of combining G3139 and irinotecan in treating patients who have metastatic or recurrent colorectal cancer.
Details: OBJECTIVES: I. Determine the dose limiting toxicities and maximum tolerated dose of bcl-2 antisense oligodeoxynucleotide G3139 (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 following therapy with G3139 at two dose levels and assess the pharmacokinetic and pharmacodynamic correlations. PROTOCOL OUTLINE: This is a dose escalation, multicenter study. Patients receive bcl-2 antisense oligodeoxynucleotide G3139 (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 toxicities. 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY 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 --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: No concurrent hormonal anticancer therapy - Radiotherapy: No concurrent radiotherapy - Surgery: See Disease Characteristics - Other: No other concurrent experimental medications --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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
AnthonyTolcher, Study Chair, San Antonio Cancer Institute
Brooke Army Medical Center
Fort Sam Houston, Texas, 78234
United States
Ireland Cancer Center
Cleveland, Ohio, 44106-5065
United States
San Antonio Cancer Institute
San Antonio, Texas, 78229
United States
Additional Information:
Study ID Numbers: CDR0000067529; SACI-IDD-98-32,NCI-T98-0094,UTHSC-IDD-98-32
Study Start Date: June 2000
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004870
Other Adenocarcinoma Of The Colon Studies:
1. NB1011 in Treating Patients With Metastatic or Recurrent Colorectal Cancer
2. Fluorouracil-Uracil and Leucovorin in Treating Elderly Patients With Metastatic Colorectal Cancer
3. Chloroquinoxaline Sulfonamide in Treating Patients With Stage IV Colorectal Cancer
4. Erlotinib in Treating Patients With Recurrent or Metastatic Colorectal Cancer
5. BMS-247550 in Treating Patients With Metastatic Colorectal Cancer
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G3139 and Irinotecan in Treating Patients With Metastatic or Recurrent Colorectal Cancer
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