Clinical trial · Interventional
Flavopiridol and Docetaxel in Treating Patients With Advanced Solid Tumors
Phase I Study Of Flavopiridol And Docetaxel (Taxotere) In Patients With Advanced Cancers
NCT00016185CI-TRIAL-00009913completedPhase 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 and docetaxel in treating patients who have advanced 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)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed metastatic or unresectable solid tumor * No standard relatively effective curative or palliative measures exist * Measurable disease in at least 1 dimension * At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan * No known clinically active and uncontrolled brain metastases PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 * Karnofsky 60-100% Life expectancy: * More than 12 weeks Hematopoietic: * WBC at least 3,000/mm\^3 * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin normal * ALT/AST no greater than 1.5 times upper limit of normal (ULN) * Alkaline phosphatase no greater than 2.5 times ULN Renal: * Creatinine normal Cardiovascular: * No symptomatic congestive heart failure * No unstable angina pectoris * No cardiac arrhythmia Other: * No prior allergic reactions to compounds of similar chemical or biologic composition to flavopiridol or docetaxel * No other uncontrolled concurrent illness that would preclude study participation * No ongoing or active infection * No psychiatric illness or social situations that would preclude study compliance * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * No concurrent immunotherapy Chemotherapy: * At least 6 months since prior taxane therapy * At least 4 weeks since other prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered * No other concurrent chemotherapy Endocrine therapy: * No concurrent hormonal therapy except contraceptives, appetite stimulants, or replacement steroids Radiotherapy: * At least 4 weeks since prior radiotherapy and recovered * No concurrent radiotherapy Surgery: * See Disease Characteristics Other: * No other concurrent investigational agents * No concurrent combination antiretroviral therapy for HIV-positive patients
References
Publications (2)
- RESULTEl-Rayes BF, Gadgeel S, Parchment R, Lorusso P, Philip PA. A phase I study of flavopiridol and docetaxel. Invest New Drugs. 2006 Jul;24(4):305-10. doi: 10.1007/s10637-005-4343-5. PMID 16683073
- RESULTPatel B, El-Rayes BF, Gadgeel SM, et al.: A phase I study of flavopiridol and docetaxel. [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-932, 2003.