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Combination Chemotherapy and Oblimersen in Treating Patients With Advanced Colorectal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00055822
Recruitment Status : Completed
First Posted : March 7, 2003
Last Update Posted : July 4, 2012
National Cancer Institute (NCI)
Information provided by (Responsible Party):
The University of Texas Health Science Center at San Antonio

Brief Summary:

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. Oblimersen may increase the effectiveness of chemotherapy by making tumor cells more sensitive to the drugs.

PURPOSE: Phase I/II trial to study the effectiveness of combining oxaliplatin, fluorouracil, and leucovorin with oblimersen in treating patients who have unresectable, metastatic, or recurrent colorectal cancer.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Biological: oblimersen sodium Drug: fluorouracil Drug: leucovorin calcium Drug: oxaliplatin Phase 1 Phase 2

Detailed Description:


  • Determine the maximum tolerated dose of oblimersen when administered with oxaliplatin, fluorouracil, and leucovorin calcium in patients with advanced colorectal cancer.
  • Determine the quantitative and qualitative toxic effects of this regimen in these patients.
  • Determine the antitumor activity of this regimen in these patients.
  • Determine the plasma pharmacokinetics of oblimersen and oxaliplatin in patients treated with this regimen.
  • Determine relevant predictive biomarkers of response in patients treated with this regimen.

OUTLINE: This is an open-label, phase I, dose-escalation study of oblimersen followed by a non-randomized, phase II study.

  • Phase I: Patients receive oblimersen IV continuously on days 1-5 and 15-19; leucovorin calcium IV over 2 hours and fluorouracil IV over 22 hours on days 6, 7, 20, and 21; and oxaliplatin IV over 2 hours on days 6 and 20.

Cohorts of 3-6 patients receive escalating doses of oblimersen until the maximum tolerated dose (MTD) is determined. The MTD is defined as the highest dose at which no more than 1 of 6 patients experiences dose-limiting toxicity.

  • Phase II: Up to 35 additional patients are treated as in phase I, with oblimersen at the MTD.

In both phases, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Patients are followed at 30 days.

PROJECTED ACCRUAL: A total of 6-53 patients (6-18 patients for phase I and 12-35 patients for phase II) will be accrued for this study.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II Study of Oblimersen Sodium (G3139, Genasense) in Combination With Oxaliplatin, 5FU and Leucovorin (FOLFOX4) Regimen in Advanced Colorectal Cancer
Study Start Date : October 2002
Actual Primary Completion Date : October 2004
Actual Study Completion Date : October 2004

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Information from the National Library of Medicine

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


  • Histologically or cytologically confirmed adenocarcinoma of the colon or rectum

    • Unresectable, metastatic, or recurrent disease
  • Measurable or evaluable disease (phase I)
  • Measurable disease (phase II)
  • No known brain metastases

    • Patients with previously treated brain metastases who are not currently receiving steroids and have a stable CT scan or MRI are eligible



  • 18 and over

Performance status

  • ECOG 0-2 OR
  • Karnofsky 60-100%

Life expectancy

  • At least 12 weeks


  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin at least 9 g/dL


  • Bilirubin no greater than 1.5 mg/dL
  • AST/ALT no greater than 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastases are present)
  • INR no greater than 1.5 times ULN (unless currently receiving anticoagulant therapy)
  • PT/PTT no greater than 1.5 times ULN (unless currently receiving anticoagulant therapy)


  • Creatinine normal OR
  • Creatinine clearance at least 60 mL/min


  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No history of allergic reaction to compounds of similar chemical or biologic composition to fluorouracil or oxaliplatin
  • No other concurrent uncontrolled medical condition that would preclude study participation
  • No ongoing or active infection
  • No psychiatric illness or social situation that would preclude study compliance
  • No known history of degenerative facet disease during prior fluorouracil therapy
  • No HIV-positive patients receiving combination antiretroviral therapy


Biologic therapy

  • No concurrent epoetin alfa during course 1
  • No concurrent routine filgrastim (G-CSF) or sargramostim (GM-CSF)
  • No concurrent immunotherapy


  • At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
  • No prior oxaliplatin
  • No other concurrent chemotherapy

Endocrine therapy

  • See Disease Characteristics


  • At least 4 weeks since prior radiotherapy and recovered
  • No concurrent radiotherapy


  • Not specified


  • No prior oblimersen
  • No other concurrent investigational agents
  • No other concurrent antitumor therapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00055822

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United States, Texas
San Antonio Cancer Institute
San Antonio, Texas, United States, 78229-3264
Sponsors and Collaborators
The University of Texas Health Science Center at San Antonio
National Cancer Institute (NCI)
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Study Chair: Anthony W. Tolcher, MD San Antonio Cancer Institute

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Responsible Party: The University of Texas Health Science Center at San Antonio Identifier: NCT00055822     History of Changes
Other Study ID Numbers: CDR0000271308
U01CA069853 ( U.S. NIH Grant/Contract )
P30CA054174 ( U.S. NIH Grant/Contract )
SACI-IDD-02-23 ( Other Identifier: San Antonio Cancer Institute )
NCI-5793 ( Other Identifier: NCI )
First Posted: March 7, 2003    Key Record Dates
Last Update Posted: July 4, 2012
Last Verified: July 2012
Keywords provided by The University of Texas Health Science Center at San Antonio:
adenocarcinoma of the colon
recurrent colon cancer
stage III colon cancer
stage IV colon cancer
adenocarcinoma of the rectum
recurrent rectal cancer
stage III rectal cancer
stage IV rectal cancer
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Physiological Effects of Drugs
Antineoplastic Agents
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors