NCT00016185

Brief Summary

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 and docetaxel in treating patients who have advanced solid tumors.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Mar 2001

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2001

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 6, 2001

Completed
1.7 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2003

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
Last Updated

April 5, 2013

Status Verified

April 1, 2013

Enrollment Period

1.9 years

First QC Date

May 6, 2001

Last Update Submit

April 3, 2013

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Interventions

alvocidibDRUG
docetaxelDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed metastatic or unresectable solid tumor * No standard relatively effective curative or palliative measures exist * Measurable disease in at least 1 dimension * At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan * No known clinically active and uncontrolled brain metastases PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 * Karnofsky 60-100% Life expectancy: * More than 12 weeks Hematopoietic: * WBC at least 3,000/mm\^3 * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin normal * ALT/AST no greater than 1.5 times upper limit of normal (ULN) * Alkaline phosphatase no greater than 2.5 times ULN Renal: * Creatinine normal Cardiovascular: * No symptomatic congestive heart failure * No unstable angina pectoris * No cardiac arrhythmia Other: * No prior allergic reactions to compounds of similar chemical or biologic composition to flavopiridol or docetaxel * No other uncontrolled concurrent illness that would preclude study participation * No ongoing or active infection * No psychiatric illness or social situations that would preclude study compliance * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * No concurrent immunotherapy Chemotherapy: * At least 6 months since prior taxane therapy * At least 4 weeks since other prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered * No other concurrent chemotherapy Endocrine therapy: * No concurrent hormonal therapy except contraceptives, appetite stimulants, or replacement steroids Radiotherapy: * At least 4 weeks since prior radiotherapy and recovered * No concurrent radiotherapy Surgery: * See Disease Characteristics Other: * No other concurrent investigational agents * No concurrent combination antiretroviral therapy for HIV-positive patients

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201-1379, United States

Location

Related Publications (2)

  • El-Rayes BF, Gadgeel S, Parchment R, Lorusso P, Philip PA. A phase I study of flavopiridol and docetaxel. Invest New Drugs. 2006 Jul;24(4):305-10. doi: 10.1007/s10637-005-4343-5.

    PMID: 16683073RESULT

  • Patel B, El-Rayes BF, Gadgeel SM, et al.: A phase I study of flavopiridol and docetaxel. [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-932, 2003.

    RESULT

MeSH Terms

Interventions

alvocidibDocetaxel

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Study Officials

  • Philip A. Philip, MD, PhD, FRCP

    Barbara Ann Karmanos Cancer Institute

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 6, 2001

First Posted

January 27, 2003

Study Start

March 1, 2001

Primary Completion

February 1, 2003

Study Completion

December 1, 2005

Last Updated

April 5, 2013

Record last verified: 2013-04

Locations

US(1)