Clinical trial · Interventional
Flavopiridol in Treating Patients With Unresectable or Metastatic Kidney Cancer
A Phase II Study of Flavopiridol 1 Hour Bolus Days 1-3 Q 21 Days in Patients With Advanced Renal Cell Cancer
NCT00016939CI-TRIAL-00011013completedPhase 2ClinicalTrials.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. PURPOSE: Phase II trial to study the effectiveness of flavopiridol in treating patients who have unresectable or metastatic kidney cancer.
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 |
|---|---|---|---|
| Kidney Cancer | Malignant Kidney Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| alvocidib | Drug | Alvocidib | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed unresectable primary (M0) or metastatic renal cell cancer * At least 1 unidimensionally measurable lesion * At least 20 mm by conventional techniques OR * At least 10 mm by spiral CT scan * Soft tissue disease that has been previously irradiated within the past 2 months is not considered measurable * Soft tissue disease within a previously irradiated field is considered measurable provided disease has progressed and other measurable disease exists outside of the radiation field * No prior or concurrent brain metastases PATIENT CHARACTERISTICS: Age: * Not specified Performance status: * Zubrod 0-2 Life expectancy: * Not specified Hematopoietic: * No hypercoagulable state other than renal cell cancer Hepatic: * Not specified Renal: * Not specified Cardiovascular: * No symptomatic congestive heart failure * No unstable angina pectoris * No cardiac arrhythmia * No prior isolated occurrence of deep venous thrombosis within the past 6 months Pulmonary: * No prior isolated occurrence of pulmonary embolism within the past 6 months Other: * No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or stage I or II cancer in complete remission * No history of allergic reactions to compounds of similar chemical or biologic composition to flavopiridol (e.g., staurosporine, deschloroflavopiridol, or butyrolactone I) * No other uncontrolled illness (e.g., diabetes mellitus) * No ongoing or active infection * No psychiatric illness or social situation that would preclude study compliance * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * 1 prior immunotherapy regimen comprising interferon and/or interleukin-2 allowed * At least 28 days since prior immunotherapy and recovered * No concurrent prophylactic filgrastim (G-CSF) Chemotherapy: * No prior chemotherapy for renal cell cancer Endocrine therapy: * Not specified Radiotherapy: * See Disease Characteristics * At least 21 days since prior radiotherapy and recovered Surgery: * See Disease Characteristics * Prior resection of primary tumor allowed * At least 28 days since prior surgery and recovered
References
Publications (1)
- RESULTVan Veldhuizen PJ, Faulkner JR, Lara PN Jr, Gumerlock PH, Goodwin JW, Dakhil SR, Gross HM, Flanigan RC, Crawford ED; Southwest Oncology Group. A phase II study of flavopiridol in patients with advanced renal cell carcinoma: results of Southwest Oncology Group Trial 0109. Cancer Chemother Pharmacol. 2005 Jul;56(1):39-45. doi: 10.1007/s00280-004-0969-9. Epub 2005 Mar 25. PMID 15791454