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

Sponsors and Collaborators:	Memorial Sloan-Kettering Cancer Center National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00046917

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, irinotecan, and cisplatin in treating patients who have advanced solid tumors.

Condition	Intervention	Phase
Unspecified Adult Solid Tumor, Protocol Specific	Drug: alvocidib Drug: cisplatin Drug: irinotecan hydrochloride	Phase I

MedlinePlus related topics: Cancer

Drug Information available for: Cisplatin Irinotecan Irinotecan hydrochloride Alvocidib Flavopiridol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment
Official Title:	An Open-Labeled, Non-Randomized Phase I Study Of Alvocidib (Flavopiridol) Administered With Irinotecan (CPT-11) And Cisplatin In Patients With Advanced Solid Tumors

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

Estimated Enrollment:	13
Study Start Date:	July 2002

Detailed Description:

OBJECTIVES:

Determine the maximum tolerated dose of flavopiridol, irinotecan, and cisplatin 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. Patients are stratified according to the number of prior treatment regimens (0 or 1 vs more than 1).

Patients receive irinotecan IV over 30 minutes followed immediately by cisplatin IV over 30 minutes followed 7 hours later by flavopiridol IV over 1-4.5 hours weekly for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of cisplatin, flavopiridol, and irinotecan until the maximum tolerated dose (MTD) of each is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, 12 additional patients are treated at the recommended phase II dose.

PROJECTED ACCRUAL: A minimum of 13 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 locally advanced or metastatic solid tumor that is refractory to standard therapy or for which no standard therapy exists
Evaluable disease
No previously untreated CNS metastasis
No primary CNS tumors

PATIENT CHARACTERISTICS:

Age

18 and over

Performance status

Karnofsky 60-100% OR
ECOG 0-2

Life expectancy

Not specified

Hematopoietic

WBC at least 3,000/mm^3
Neutrophil count at least 1,500/mm^3
Platelet count at least 100,000/mm^3

Hepatic

Bilirubin no greater than 2.0 mg/dL
AST and ALT no greater than 3 times upper limit of normal (ULN) (5 times ULN if liver metastases are present)

Renal

Creatinine no greater than 1.5 mg/dL OR
Creatinine clearance at least 60 mL/min

Cardiovascular

No cardiac arrhythmia
No congestive heart failure
No myocardial infarction within the past 6 months

Other

HIV negative
No neuropathy grade 2 or greater
No serious or uncontrolled infection
No other medical condition or reason that would preclude study participation
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception during and for at least 2 months after study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

At least 4 weeks since prior immunotherapy

Chemotherapy

At least 1 week since prior irinotecan and cisplatin alone
At least 4 weeks since other prior chemotherapy (6 weeks for nitrosoureas or mitomycin)

Endocrine therapy

Not specified

Radiotherapy

At least 4 weeks since prior radiotherapy

Surgery

Not specified

Other

Recovered from all prior therapy
No concurrent vitamins, antioxidants, or herbal supplements except a daily multivitamin
No other concurrent investigational drugs

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00046917

Locations

United States, New York
Memorial Sloan-Kettering Cancer Center	Recruiting
New York, New York, United States, 10021
Contact: Gary K. Schwartz, MD 212-639-8324

Sponsors and Collaborators

Memorial Sloan-Kettering Cancer Center

National Cancer Institute (NCI)

Investigators

Study Chair:	Manish A. Shah, MD	Memorial Sloan-Kettering Cancer Center
Investigator:	Gary K. Schwartz, MD	Memorial Sloan-Kettering Cancer Center

More Information

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

Publications of Results:

Shah MA, Kortmansky J, Gonen M, et al.: A phase I study of weekly irinotecan (CPT), cisplatin (CIS) and flavopiridol (F). [Abstract] J Clin Oncol 22 (14 Suppl): A-4027, 320s, 2004.

Study ID Numbers:	CDR0000257034, MSKCC-02043, NCI-5700
Study First Received:	October 3, 2002
Last Updated:	December 16, 2008
ClinicalTrials.gov Identifier:	NCT00046917
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

unspecified adult solid tumor, protocol specific

Study placed in the following topic categories:

Flavopiridol
Cisplatin
Irinotecan
Camptothecin

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Radiation-Sensitizing Agents
Antineoplastic Agents
Therapeutic Uses

Physiological Effects of Drugs
Enzyme Inhibitors
Antineoplastic Agents, Phytogenic
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009