Clinical trial · Interventional
Flavopiridol in Treating Patients With Recurrent or Metastatic Head and Neck Cancer
A Phase II Trial of Daily Bolus Flavopiridol for Five Consecutive Days in Patients With Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)
- 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 work in 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 recurrent or metastatic head and neck cancer.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Thromboembolism | — | UNRESOLVED | — |
Interventions
Interventions (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically proven squamous cell carcinoma of the head and neck * Metastatic disease at diagnosis OR * Persistent, metastatic, or recurrent disease after prior definitive surgery and/or radiotherapy * No undifferentiated and nonkeratinizing carcinomas, including lymphoepitheliomas of all locations * No nasopharynx tumors * Bidimensionally measurable disease * Patients whose only measurable disease is within a prior radiotherapy port must have clearly progressive disease * No metastatic or leptomeningeal CNS disease PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 Life expectancy: * Not specified Hematopoietic: * Platelet count greater than 100,000/mm\^3 * Absolute granulocyte count greater than 1,500/mm\^3 Hepatic: * See Other (Prior/Concurrent Therapy) * SGOT and SGPT less than 2.5 times normal * Bilirubin less than 1.5 times normal * No history of hypercoagulopathies (e.g., protein C deficiency, protein S deficiency, or lupus anticoagulant) Renal: * Creatinine no greater than 1.5 mg/dL OR * Creatinine clearance at least 60 mL/min * Calcium no greater than normal * No hypercalcemia refractory to bisphosphonates Cardiovascular: * No unstable or newly diagnosed angina pectoris * No myocardial infarction within the past 6 months * No class II-IV congestive heart failure * No history of symptomatic carotid disease * No concurrent asymptomatic carotid artery occlusion (70% or greater) in one or both arteries by Doppler ultrasound * No symptomatic atherosclerosis * No thrombotic events within the past 6 months Pulmonary: * No aspirin-induced asthma Other: * No inability to take aspirin or clopidogrel bisulfate due to contraindications, allergies, or pre-existing medical conditions (e.g., active peptic ulcer disease or history of undiagnosed non-occult, non-hemorrhoidal gastrointestinal or other bleeding sources within the past 6 months) * No other prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer that is currently in complete remission * HIV negative * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 3 months after study PRIOR CONCURRENT THERAPY: Biologic therapy: * No concurrent biologic therapy Chemotherapy: * At least 4 weeks since prior chemotherapy and recovered * No prior flavopiridol * No more than 3 prior systemic chemotherapy regimens for recurrent or metastatic disease * No other concurrent chemotherapy Endocrine therapy: * No concurrent hormonal therapy except oral contraceptives Radiotherapy: * See Disease Characteristics * At least 4 weeks since prior radiotherapy and recovered * No concurrent radiotherapy Surgery: * See Disease Characteristics * At least 4 weeks since prior surgery and recovered * No prior carotid endarterectomy or other revascularization surgery Other: * No other concurrent antineoplastic therapies * No active anticoagulation with INR 1.5 or greater * No low-molecular weight heparin or equivalent * Concurrent bisphosphonates for calcium maintenance allowed
References
Publications (0)
Data not yet available