Flavopiridol, Gemcitabine, and Irinotecan in Treating Patients With Unresectable or Metastatic Solid Tumors

Part of paid clinical trials in Albuquerque, New Mexico.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT00079352
Phase
PHASE1
Status
Completed

Conditions

  • Unspecified Adult Solid Tumor, Protocol Specific

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

This phase I trial is studying the side effects and best dose of flavopiridol when given together with gemcitabine and irinotecan in treating patients with unresectable or metastatic solid tumors. Drugs used in chemotherapy, such as flavopiridol, gemcitabine, and irinotecan, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells

Key Dates

Start date
Apr 30, 2004
Status verified
Jan 2013
Primary completion
Oct 31, 2007

Study Design

Enrollment
24 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (gemcitabine, irinotecan, alvocidib)
    Patients receive gemcitabine IV over 30 minutes followed by irinotecan IV over 30 minutes on days 1 and 15. Patients also receive flavopiridol IV over 60 minutes on days 2 and 16. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Recommended phase II dose of flavopiridol defined as the highest dose for which no more than one patient develop a >= grade 3 toxicity [ Time Frame: 28 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of New MexicoAlbuquerqueNew Mexico87106-

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By research site
University of New Mexico· Albuquerque, NM

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