Clinical trial · Interventional
Docetaxel and Flavopiridol in Treating Patients With Locally Advanced or Metastatic Breast Cancer
A Phase I/II Trial of Docetaxel Followed by Infusional Flavopiridol Over 72 Hours in Patients With Previously Treated Locally Advanced or Metastatic Breast Cancer
NCT00020332CI-TRIAL-00010732completedPhase 1 / Phase 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. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy in treating patients who have locally advanced or metastatic breast 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 |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed stage III or IV adenocarcinoma of the breast * Phase I: * Evaluable disease allowed * Phase II: * At least 1 site of measurable disease * No bone metastasis as only site of disease * No carcinomatous meningitis or brain metastases * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age: * 18 and over Sex: * Male or female Menopausal status: * Not specified Performance status: * ECOG 0-2 Life expectancy: * Not specified Hematopoietic: * Granulocyte count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * No active coagulopathy requiring therapeutic anticoagulation Hepatic: * Bilirubin no greater than upper limit of normal (ULN) * SGOT no greater than 1.5 times ULN * Alkaline phosphatase no greater than 2.5 times ULN * No Gilbert's disease Renal: * Creatinine no greater than 1.5 mg/dL Cardiovascular: * Left ventricular ejection fraction at least 50% without clinical signs or symptoms of heart failure * No uncontrolled hypertension (sustained systolic blood pressure (BP) greater than 180 mm Hg or diastolic BP greater than 100 mm Hg) * No uncontrolled cardiac arrhythmia * No myocardial infarction within the past year * No significant ischemia or valvular heart disease Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No medical or psychiatric condition that would increase risk * No other malignancy within the past 5 years except carcinoma in situ of the cervix or nonmelanomatous skin cancer * No grade 2 or greater peripheral neuropathy * No diabetes mellitus with a fasting blood sugar greater than 200 mg/dL * No active unresolved infection * No serious concurrent medical illness * No history of hypersensitivity reaction to products containing polysorbate 80 (Tween 80) PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * No prior flavopiridol * Prior adjuvant chemotherapy for advanced disease allowed if within 6 months of diagnosis of metastatic disease * At least 4 weeks since prior chemotherapy (6 weeks for nitrosourea or 8 weeks for UCN-01) and recovered * Phase I: * Any number of prior chemotherapy regimens for metastatic carcinoma of the breast allowed * Phase II: * No more than 2 prior chemotherapy regimens for metastatic carcinoma of the breast Endocrine therapy: * Prior hormonal therapy in the metastatic or adjuvant setting allowed * At least 2 weeks since prior hormonal therapy and no evidence of disease improvement by radiography after therapy * Concurrent corticosteroids allowed if for study premedication or hypersensitivity reactions/adverse events Radiotherapy: * No concurrent radiotherapy Surgery: * Not specified Other: * No other concurrent antineoplastic therapies * No other concurrent investigational drugs
References
Publications (0)
Data not yet available
No reference posted for this study.