Clinical trial · Interventional
Alvocidib, Oxaliplatin, Fluorouracil, and Leucovorin Calcium in Treating Patients With Advanced Solid Tumors
An Open-Labeled, Non-Randomized Phase I Study of Alvocidib (Flavopiridol) Administered With Oxaliplatin and Fluorouracil/Leucovorin in Patients With Advanced 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 alvocidib when given together with oxaliplatin, fluorouracil, and leucovorin calcium in treating patients with advanced solid tumors. Drugs used in chemotherapy, such as alvocidib, oxaliplatin, fluorouracil, and leucovorin calcium, work in different ways to stop tumor cells from dividing so they stop growing or die. Alvocidib may also make tumor cells more sensitive to chemotherapy. Combining more than one chemotherapy drug may kill more tumor cells.
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 |
|---|---|---|---|
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| alvocidib | Drug | Alvocidib | ALIAS |
| fluorouracil | Drug | Fluorouracil | ALIAS |
| leucovorin calcium | Drug | Leucovorin | ALIAS |
| oxaliplatin | Drug | Oxaliplatin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (alvocidib with oxaliplatin, 5-FU, leucovorin)
- description
- Patients receive alvocidib IV over 1 hour, oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV continuously over 48 hours on days 1, 15, and 29. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of flavopiridol 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. Once the MTD is determined, the cohort is expanded and an additional 10 patients are treated at that dose.
- interventionNames
- Drug: alvocidib
- Drug: fluorouracil
- Drug: oxaliplatin
- Drug: leucovorin calcium
Primary outcomes (1)
- measure
- Maximum tolerated dose of biweekly alvocidib when given in conjunction with oxaliplatin, 5-fluorouracil, and leucovorin calcium
- timeFrame
- 6 weeks
- description
- Defined as the dose level immediately preceding the dose where 2 or more patients experienced dose-limiting toxicity.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed advanced solid tumor * Refractory to standard therapy or no standard therapy exists * Evaluable disease * No known untreated CNS metastases * Patients who have undergone local treatment for brain metastases and whose brain metastases are stable by repeat imaging study performed ≤ 4 weeks after treatment are allowed * No primary CNS tumors * Performance status - Karnofsky 60-100% * WBC ≥ 3,500/mm\^3 * Neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Bilirubin ≤ 1.5 mg/dL * AST and ALT ≤ 2.5 times upper limit of normal (ULN) (5 times ULN for liver metastases) * Creatinine ≤ 1.5 mg/dL * No cardiac arrhythmias within the past 6 months * No congestive heart failure within the past 6 months * No myocardial infarction within the past 6 months * No arterial or venous thrombosis within the past year * No peripheral neuropathy \> grade 1 * No other medical condition that would preclude study participation * No serious or uncontrolled infection * HIV negative * Not pregnant or nursing * No nursing during and for 2 months after study participation * Negative pregnancy test * Fertile patients must use effective contraception during and for 2 months after study participation * At least 2 weeks since prior immunotherapy * At least 2 weeks since prior chemotherapy (6 weeks for nitrosoureas and mitomycin) * No prior flavopiridol * At least 2 weeks since prior radiotherapy * Recovered from all prior therapy * No concurrent therapy for thrombosis * Prophylaxis for central lines or deep vein thrombosis allowed * No other concurrent investigational medications * No concurrent vitamins, antioxidants, or herbal preparations and supplements * Concurrent single-tablet multivitamin allowed
References
Publications (0)
Data not yet available