Clinical trial · Interventional
Combination Chemotherapy in Treating Patients With Advanced Solid Tumors
An Open-Labeled, Non-Randomized Phase I Study of Alvocidib (Flavopiridol) Administered With Irinotecan (CPT-11) and Cisplatin in Patients With Advanced Solid Tumors
NCT00046917CI-TRIAL-00013852completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- 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)
Phase I trial to study the effectiveness of combining alvocidib, irinotecan hydrochloride, and cisplatin in treating patients who have advanced solid tumors. 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.
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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| alvocidib | Drug | Alvocidib | ALIAS |
| cisplatin | Drug | Cisplatin | ALIAS |
| irinotecan hydrochloride | Drug | Irinotecan | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (chemotherapy)
- description
- Patients are stratified according to the number of prior treatment regimens (0 or 1 vs more than 1). Patients receive irinotecan hydrochloride IV over 30 minutes followed immediately by cisplatin IV over 30 minutes followed 7 hours later by alvocidib IV over 1-4.5 hours weekly for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: alvocidib
- Drug: irinotecan hydrochloride
- Drug: cisplatin
Primary outcomes (1)
- measure
- MTD alvocidib when administered in conjunction with irinotecan hydrochloride and cisplatin
- timeFrame
- Course 1
- description
- Defined as the dose one level below the dose at which two or more of the patients in the initial cohort experience dose limiting toxicity (DLT) during the first treatment course. DLT is defined as the occurrence of Grade 4 hematologic toxicity, Grade 3 or 4 non-hematologic toxicity including diarrhea despite antidiarrheal prophylaxis, or any delay in treatment resulting in less than 2 treatments in 3 weeks.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed locally advanced or metastatic solid tumor that is refractory to standard therapy or for which no standard therapy exists * Evaluable disease * No previously untreated CNS metastasis * No primary CNS tumors * Performance status - Karnofsky 60-100% * Performance status - ECOG 0-2 * Not specified * WBC at least 3,000/mm\^3 * Neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * Bilirubin no greater than 2.0 mg/dL * AST and ALT no greater than 3 times upper limit of normal (ULN) (5 times ULN if liver metastases are present) * Creatinine no greater than 1.5 mg/dL * Creatinine clearance at least 60 mL/min * No cardiac arrhythmia * No congestive heart failure * No myocardial infarction within the past 6 months * HIV negative * No neuropathy grade 2 or greater * No serious or uncontrolled infection * No other medical condition or reason that would preclude study participation * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for at least 2 months after study participation * At least 4 weeks since prior immunotherapy * At least 1 week since prior irinotecan and cisplatin alone * At least 4 weeks since other prior chemotherapy (6 weeks for nitrosoureas or mitomycin) * Not specified * At least 4 weeks since prior radiotherapy * Not specified * Recovered from all prior therapy * No concurrent vitamins, antioxidants, or herbal supplements except a daily multivitamin * No other concurrent investigational drugs
References
Publications (0)
Data not yet available
No reference posted for this study.