Clinical trial · Interventional
Combination Chemotherapy and Oblimersen in Treating Patients With Advanced Colorectal Cancer
A Phase I/II Study of Oblimersen Sodium (G3139, Genasense) in Combination With Oxaliplatin, 5FU and Leucovorin (FOLFOX4) Regimen in Advanced Colorectal Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| fluorouracil | Drug | Fluorouracil | ALIAS |
| leucovorin calcium | Drug | Leucovorin | ALIAS |
| oblimersen sodium | Biological | — | UNRESOLVED |
| oxaliplatin | Drug | Oxaliplatin | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
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