Clinical trial · Interventional
Flavopiridol and Irinotecan in Treating Patients With Advanced Solid Tumors
An Open-Labeled, Non-Randomized Phase I Study Of Flavopiridol Administered With Irinotecan (CPT-11) In Patients With Advanced Solid Tumors
NCT00006485CI-TRIAL-00002891completedPhase 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)
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. PURPOSE: Phase I trial to study the effectiveness of combining flavopiridol with irinotecan in treating patients who have locally advanced or metastatic solid tumors.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| alvocidib | Drug | Alvocidib | ALIAS |
| irinotecan hydrochloride | Drug | Irinotecan | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically proven locally advanced or metastatic solid tumor that is refractory to standard therapy or for which no standard therapy exists * Eligible for treatment at the maximum tolerated dose only if disease accessible for tissue biopsy by Tru-Cut, CT guidance, or endoscopy * Pleural effusions or abdominal ascites do not constitute adequate tissue for biopsy * No known CNS metastasis or primary CNS tumor PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Karnofsky 60-100% Life expectancy: * Not specified Hematopoietic: * WBC at least 3,500/mm\^3 * Total neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin no greater than 1.5 mg/dL * SGOT and SGPT no greater than 2.5 times upper limit of normal Renal: * Creatinine no greater than 1.5 mg/dL Cardiovascular: * No cardiac arrhythmias, congestive heart failure, or myocardial infarction within the past 6 months Other: * Not pregnant or nursing (during and for at least 2 months after study) * Negative pregnancy test * Fertile patients must use effective contraception during and for at least 2 months after study * No concurrent serious or uncontrolled infection * HIV negative * No other medical condition that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 4 weeks since prior immunotherapy and recovered Chemotherapy: * At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered * Prior irinotecan allowed Endocrine therapy: * Not specified Radiotherapy: * At least 4 weeks since prior radiotherapy and recovered Surgery: * See Disease Characteristics Other: * Recovered from prior therapy * No other concurrent investigational medication * No concurrent vitamins (except a single multivitamin tablet), antioxidants, or herbal preparations or supplements * No concurrent subcutaneous heparin or heparinoids
References
Publications (0)
Data not yet available
No reference posted for this study.