Clinical trial · Interventional
Suberoylanilide Hydroxamic Acid, Fluorouracil, Leucovorin, and Oxaliplatin in Treating Patients With Progressive Metastatic or Unresectable Colorectal Cancer or Other Solid Tumors
A Phase I Study of Suberoylanilide Hydroxamic Acid (Vorinostat) in Combination With 5-Fluorouracil, Leucovorin, and Oxaliplatin (mFOLFOX) in Patients With Colorectal Cancer and Other Solid Tumors
- 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)
This phase I trial is studying the side effects and best dose of suberoylanilide hydroxamic acid when given together with fluorouracil, leucovorin, and oxaliplatin in treating patients with progressive metastatic or unresectable colorectal cancer or solid tumor. Drugs used in chemotherapy, such as suberoylanilide hydroxamic acid, fluorouracil, leucovorin, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Suberoylanilide hydroxamic acid may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Recurrent Colon Cancer | Malignant Colon Neoplasm | CURATED_BROADER | 0.78 |
| Recurrent Rectal Cancer | Malignant Rectal Neoplasm | CURATED_BROADER | 0.78 |
| Stage III Colon Cancer | Malignant Colon Neoplasm | CURATED_BROADER | 0.78 |
| Stage III Rectal Cancer | Malignant Rectal Neoplasm | CURATED_BROADER | 0.78 |
| Stage IV Colon Cancer | Malignant Colon Neoplasm | CURATED_BROADER | 0.78 |
| Stage IV Rectal Cancer | Malignant Rectal Neoplasm | CURATED_BROADER | 0.78 |
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| fluorouracil | Drug | Fluorouracil | ALIAS |
| leucovorin calcium | Drug | Leucovorin | ALIAS |
| oxaliplatin | Drug | Oxaliplatin | ALIAS |
| vorinostat | Drug | Vorinostat | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (vorinostat, mFOLFOX)
- description
- Patients receive oral SAHA once or twice daily on days 1-3. Patients also receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 4 followed by fluorouracil IV over 46 hours on days 4-5. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of SAHA until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. A total of 10 patients are treated at the MTD.
- interventionNames
- Drug: oxaliplatin
- Drug: leucovorin calcium
- Drug: vorinostat
- Drug: fluorouracil
Primary outcomes (2)
- measure
- Maximum tolerated dose of vorinostat
- timeFrame
- 2 weeks
- description
- Graded according to the NCI CTCAE.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed colorectal cancer * Metastatic or unresectable disease OR diagnosis of solid tumor * No known brain metastases * ECOG 0-1 OR Karnofsky 70-100% * Life expectancy \> 12 weeks * Absolute neutrophil count ≥ 1,500/mm\^3 * WBC ≥ 3,000/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Bilirubin normal * AST and ALT ≤ 3 times upper limit of normal * Creatinine normal OR creatinine clearance ≥ 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 during and for 3 months after study participation * No ongoing or active infection * No neuropathy \> grade 1 * No history of allergic reaction attributed to compounds of similar chemical or biological composition to study drugs * No psychiatric illness or social situation that would preclude study compliance * No psychiatric illness or social situation that would preclude study compliance * No other uncontrolled illness * Prior bevacizumab and/or cetuximab allowed * No concurrent routine or prophylactic filgrastim (G-CSF) or sargramostim (GM-CSF) * More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) * More than 4 weeks since prior radiotherapy * Recovered from prior therapy * At least 2 weeks since prior valproic acid * No concurrent combination anti-retroviral therapy for HIV-positive patients * No other concurrent investigational agents * No other concurrent anticancer therapy
References
Publications (0)
Data not yet available