Combination Chemotherapy in Treating Patients With Advanced Solid Tumors - Full Text View

Sponsored by:	Memorial Sloan-Kettering Cancer Center
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00045448

Purpose

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 with docetaxel in treating patients who have advanced solid tumors.

Condition	Intervention	Phase
Unspecified Adult Solid Tumor, Protocol Specific	Drug: alvocidib Drug: docetaxel	Phase I

MedlinePlus related topics: Cancer

Drug Information available for: Docetaxel Alvocidib Flavopiridol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment
Official Title:	Single Center Open-Label Non-Comparative Phase I Dose Finding Study Of Weekly Flavopiridol In Combination With Weekly Docetaxel In Patients With Advanced Solid Tumors

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:

April 2002

Detailed Description:

OBJECTIVES:

Determine the maximum tolerated dose of flavopiridol when administered in combination with 2 different doses of docetaxel in patients with advanced solid tumors.
Determine the clinical pharmacokinetics of this regimen in these patients.
Determine, preliminarily, the therapeutic activity of this regimen in these patients.

OUTLINE: This is a dose-escalation study of flavopiridol.

Patients receive docetaxel IV over 30 minutes followed at least 4 hours later by flavopiridol IV over 1 hour on days 1, 8, and 15. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of flavopiridol until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity. Separate MTDs of flavopiridol are determined when flavopiridol is combined with 2 different doses of docetaxel. A total of 10 patients are treated at each flavopiridol MTD.

Patients are followed every 3 months for 1 year, every 6 months for 1 year, and then annually thereafter.

PROJECTED ACCRUAL: A total of 6-56 patients will be accrued for this study.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed advanced solid tumor that is refractory to standard therapy or for which no standard therapy exists
Measurable or evaluable disease
No symptomatic or untreated CNS metastases or primary CNS neoplasm

PATIENT CHARACTERISTICS:

Age

18 and over

Performance status

Karnofsky 70-100%

Life expectancy

Not specified

Hematopoietic

WBC at least 3,500/mm3
Absolute neutrophil count at least 1,500/mm3
Platelet count at least 100,000/mm3
Hemoglobin at least 8 g/dL

Hepatic

Bilirubin no greater than upper limit of normal (ULN)
SGOT/SGPT no greater than 2.5 times ULN if alkaline phosphatase no greater than ULN OR
Alkaline phosphatase no greater than 2.5 times ULN if SGOT/SGPT no greater than ULN

Renal

Creatinine no greater than 1.5 mg/dL

Cardiovascular

No history of cardiac arrhythmias
No congestive heart failure
No myocardial infarction within the past 6 months

Other

No concurrent serious or uncontrolled infection
No diabetes not adequately controlled with medication
No peripheral neuropathy greater than grade 1
No known allergy to docetaxel or other medications formulated in Polysorbate 80
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception during and for 2 months after study

PRIOR CONCURRENT THERAPY:

Biologic therapy

At least 4 weeks since prior immunotherapy

Chemotherapy

At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
Prior taxanes allowed
No prior flavopiridol

Endocrine therapy

At least 4 weeks since prior hormonal therapy

Radiotherapy

At least 4 weeks since prior radiotherapy

Surgery

Not specified

Other

Recovered from prior therapy
No prior enrollment in this study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00045448

Locations

United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021

Sponsors and Collaborators

Memorial Sloan-Kettering Cancer Center

Investigators

Study Chair:

Gary K. Schwartz, MD

Memorial Sloan-Kettering Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000256563, MSKCC-02034, NCI-G02-2106, AVENTIS-HMR1275A/1501
Study First Received:	September 6, 2002
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00045448 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

unspecified adult solid tumor, protocol specific

Study placed in the following topic categories:

Docetaxel
Flavopiridol
Signs and Symptoms

Additional relevant MeSH terms:

Docetaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009