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| Sponsor: | Dana-Farber Cancer Institute |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00070239 |
Purpose
RATIONALE: Drugs used in chemotherapy, such as flavopiridol, work in different ways to stop cancer cells from dividing so they stop growing or die.
PURPOSE: This phase I trial is studying the side effects and best dose of flavopiridol in treating patients with metastatic or unresectable refractory solid tumors or hematologic malignancies.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer Head and Neck Cancer Intraocular Melanoma Kidney Cancer Leukemia Lung Cancer Lymphoma Malignant Mesothelioma Melanoma (Skin) Multiple Myeloma and Plasma Cell Neoplasm Sarcoma Small Intestine Cancer |
Drug: alvocidib |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | A Phase I Clinical, Pharmacokinetic, and Pharmacodynamic Study of Novel Flavopiridol in Patients With Refractory Solid Tumors and Hematologic Malignancies |
| Estimated Enrollment: | 80 |
| Study Start Date: | October 2003 |
| Estimated Primary Completion Date: | June 2006 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a 2-part, dose-escalation, multicenter study.
Cohorts of 3-6 patients receive escalating doses of flavopiridol until the maximum tolerated dose (MTD)* is determined.
Cohorts of 3-6 patients receive escalating durations of the maintenance dose of flavopiridol until the MTD* is determined. An additional cohort of 10-20 patients receives flavopiridol over 1 hour on days 1 and 15 at the MTD.
NOTE: *The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
In both parts, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients are followed at 1 month and then every 2 months thereafter.
PROJECTED ACCRUAL: Approximately 3-80 patients will be accrued for this study within 1-4 years.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed malignancy, including the following types:
Hematologic malignancy, including any of the following: (Accrual for patients with hematologic malignancies temporarily closed as of 11/30/04)
Mantle cell lymphoma
Chronic lymphocytic leukemia
Rai stage III or IV and meeting at least 1 of the following criteria for active disease:
Multiple myeloma
Solid tumor, including but not limited to any of the following:
Breast cancer
HER-2 positivity not required for study enrollment
Small cell lung cancer
Squamous cell carcinoma of the head and neck
Mesothelioma
Measurable or nonmeasurable disease (solid tumor patients)
Nonmeasurable disease includes any of the following:
Previously treated with at least 1 chemotherapy regimen*
No active CNS metastases
History of CNS metastases allowed provided all of the following criteria are met:
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age
Sex
Menopausal status
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Gastrointestinal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations| United States, Massachusetts | |
| Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | |
| Boston, Massachusetts, United States, 02115 | |
| Principal Investigator: | Geoffrey Shapiro, MD, PhD | Dana-Farber Cancer Institute |
More Information
| Study ID Numbers: | CDR0000331689, DFCI-03082, NCI-6052 |
| Study First Received: | October 3, 2003 |
| Last Updated: | January 28, 2009 |
| ClinicalTrials.gov Identifier: | NCT00070239 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
stage IV mantle cell lymphoma recurrent mantle cell lymphoma recurrent breast cancer stage IV breast cancer extensive stage small cell lung cancer limited stage small cell lung cancer recurrent squamous cell carcinoma of the lip and oral cavity stage IV squamous cell carcinoma of the lip and oral cavity recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity metastatic squamous neck cancer with occult primary squamous cell carcinoma recurrent metastatic squamous neck cancer with occult primary salivary gland squamous cell carcinoma stage IV salivary gland cancer recurrent salivary gland cancer |
recurrent squamous cell carcinoma of the hypopharynx stage IV squamous cell carcinoma of the hypopharynx recurrent squamous cell carcinoma of the larynx stage IV squamous cell carcinoma of the larynx recurrent squamous cell carcinoma of the nasopharynx recurrent squamous cell carcinoma of the oropharynx stage IV squamous cell carcinoma of the nasopharynx stage IV squamous cell carcinoma of the oropharynx recurrent small cell lung cancer refractory chronic lymphocytic leukemia recurrent renal cell cancer stage III renal cell cancer stage IV renal cell cancer epithelial mesothelioma recurrent malignant mesothelioma |
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Thoracic Neoplasms Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Urogenital Neoplasms Urologic Neoplasms Protein Kinase Inhibitors Ileal Diseases Duodenal Neoplasms Neoplasms, Connective and Soft Tissue Hemorrhagic Disorders Neoplasms by Site Lung Neoplasms Therapeutic Uses Cardiovascular Diseases Kidney Diseases |
Breast Diseases Digestive System Neoplasms Immunoproliferative Disorders Eye Neoplasms Immune System Diseases Hematologic Diseases Breast Neoplasms Carcinoma Multiple Myeloma Neuroectodermal Tumors Neoplasms Lung Diseases Sarcoma Gastrointestinal Neoplasms Neoplasms, Glandular and Epithelial |