Combination Chemotherapy and Oblimersen in Treating Patients With Advanced Colorectal Cancer
This study has been completed.
Sponsor:
The University of Texas Health Science Center at San Antonio
Collaborator:
Information provided by (Responsible Party):
The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier:
NCT00055822
First received: March 6, 2003
Last updated: July 3, 2012
Last verified: July 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Colorectal Cancer |
Biological: oblimersen sodium Drug: fluorouracil Drug: leucovorin calcium Drug: oxaliplatin |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: 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 |
Resource links provided by NLM:
Further study details as provided by The University of Texas Health Science Center at San Antonio:
| Enrollment: | 16 |
| Study Start Date: | October 2002 |
| Study Completion Date: | October 2004 |
| Primary Completion Date: | October 2004 (Final data collection date for primary outcome measure) |
OBJECTIVES:
- 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
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
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-2 OR
- Karnofsky 60-100%
Life expectancy
- At least 12 weeks
Hematopoietic
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
- Hemoglobin at least 9 g/dL
Hepatic
- 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)
Renal
- Creatinine normal OR
- Creatinine clearance at least 60 mL/min
Cardiovascular
- No symptomatic congestive heart failure
- No unstable angina pectoris
- No cardiac arrhythmia
Other
- 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
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No concurrent epoetin alfa during course 1
- No concurrent routine filgrastim (G-CSF) or sargramostim (GM-CSF)
- No concurrent immunotherapy
Chemotherapy
- 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
Radiotherapy
- At least 4 weeks since prior radiotherapy and recovered
- No concurrent radiotherapy
Surgery
- Not specified
Other
- No prior oblimersen
- No other concurrent investigational agents
- No other concurrent antitumor therapy
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00055822
Locations
| 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
Investigators
| Study Chair: | Anthony W. Tolcher, MD | San Antonio Cancer Institute |
More Information
Additional Information:
No publications provided
| Responsible Party: | The University of Texas Health Science Center at San Antonio |
| ClinicalTrials.gov Identifier: | NCT00055822 History of Changes |
| Other Study ID Numbers: | CDR0000271308, U01CA069853, P30CA054174, SACI-IDD-02-23, NCI-5793 |
| Study First Received: | March 6, 2003 |
| Last Updated: | July 3, 2012 |
| Health Authority: | United States: Food and Drug Administration United States: Institutional Review Board |
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:
|
Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Fluorouracil Oxaliplatin Leucovorin Levoleucovorin |
Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antimetabolites, Antineoplastic Antineoplastic Agents Therapeutic Uses Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Vitamin B Complex Vitamins Micronutrients Growth Substances Antidotes Protective Agents |
ClinicalTrials.gov processed this record on May 23, 2013