NCT00055822CompletedPhase 1
A Phase I/II Study of Oblimersen Sodium (G3139, Genasense) in Combination With Oxaliplatin, 5FU and Leucovorin (FOLFOX4) Regimen in Advanced Colorectal Cancer
The University of Texas Health Science Center at San Antonio2 sites in 1 country16 target enrollmentStarted: October 1, 2002Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 16
- Locations
- 2
Study Overview
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion 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:
- •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
- •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
- •Cardiovascular
- •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
- •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
- +5 more not shown
Exclusion Criteria
- Not provided
Investigators
Study Sites (2)
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