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Flavopiridol and Irinotecan in Treating Patients With Advanced Solid Tumors

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ClinicalTrials.gov Identifier: NCT00006485
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : December 15, 2009
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

November 6, 2000
January 27, 2003
December 15, 2009
September 2000
December 2003   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00006485 on ClinicalTrials.gov Archive Site
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Flavopiridol and Irinotecan in Treating Patients With Advanced Solid Tumors
An Open-Labeled, Non-Randomized Phase I Study Of Flavopiridol Administered With Irinotecan (CPT-11) In Patients With Advanced Solid Tumors

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 irinotecan in treating patients who have locally advanced or metastatic solid tumors.


  • Determine the maximum tolerated dose of flavopiridol when combined with irinotecan in patients with advanced solid tumors.
  • Determine the clinical pharmacokinetics of this regimen, as well as the plasma levels of the active metabolite SN-38 and metabolic product SN-38 glucuronide in these patients.
  • Determine, in a preliminary manner, the therapeutic activity of this regimen in these patients.
  • Determine the role of p21 relative to treatment response and apoptosis in these patients treated with this regimen.

OUTLINE: This is a dose-escalation, open-label, non-randomized study of flavopiridol.

Patients receive irinotecan IV over 30 minutes followed 7 hours later by flavopiridol IV over 1 hour on days 1, 8, 15, and 22. Treatment continues every 6 weeks for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity. During the first week of the second course, patients receive flavopiridol alone on day 1 and irinotecan alone on day 2.

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 2 or more of 6 patients in the initial cohort experience dose limiting toxicity during the first course of treatment. An additional 10 patients are treated at the MTD.

PROJECTED ACCRUAL: A total of 44-50 patients will be accrued for this study within 1 year.

Phase 1
Allocation: Non-Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Unspecified Adult Solid Tumor, Protocol Specific
  • Drug: alvocidib
  • Drug: irinotecan hydrochloride
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
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December 2003   (Final data collection date for primary outcome measure)


  • Histologically proven locally advanced or metastatic solid tumor that is refractory to standard therapy or for which no standard therapy exists
  • Eligible for treatment at the maximum tolerated dose only if disease accessible for tissue biopsy by Tru-Cut, CT guidance, or endoscopy

    • Pleural effusions or abdominal ascites do not constitute adequate tissue for biopsy
  • No known CNS metastasis or primary CNS tumor



  • 18 and over

Performance status:

  • Karnofsky 60-100%

Life expectancy:

  • Not specified


  • WBC at least 3,500/mm^3
  • Total neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3


  • Bilirubin no greater than 1.5 mg/dL
  • SGOT and SGPT no greater than 2.5 times upper limit of normal


  • Creatinine no greater than 1.5 mg/dL


  • No cardiac arrhythmias, congestive heart failure, or myocardial infarction within the past 6 months


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


Biologic therapy:

  • At least 4 weeks since prior immunotherapy and recovered


  • At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
  • Prior irinotecan allowed

Endocrine therapy:

  • Not specified


  • At least 4 weeks since prior radiotherapy and recovered


  • See Disease Characteristics


  • Recovered from prior therapy
  • No other concurrent investigational medication
  • No concurrent vitamins (except a single multivitamin tablet), antioxidants, or herbal preparations or supplements
  • No concurrent subcutaneous heparin or heparinoids
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
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Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI)
Study Chair: Gary K. Schwartz, MD Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI)
June 2003

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP