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Flavopiridol in Treating Patients With Locally Advanced or Metastatic Solid Tumors
This study is ongoing, but not recruiting participants.
Study NCT00112684   Information provided by National Cancer Institute (NCI)
First Received: June 2, 2005   Last Updated: July 22, 2009   History of Changes

June 2, 2005
July 22, 2009
February 2006
November 2006   (final data collection date for primary outcome measure)
 
 
Complete list of historical versions of study NCT00112684 on ClinicalTrials.gov Archive Site
 
 
 
Flavopiridol in Treating Patients With Locally Advanced or Metastatic Solid Tumors
A Pilot Study of Flavopiridol in Patients With Advanced Solid Tumors

RATIONALE: Drugs used in chemotherapy, such as flavopiridol, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Flavopiridol may also stimulate the immune system in different ways and stop tumor cells from growing. It may also stop the growth of solid tumors by blocking blood flow to the tumor.

PURPOSE: This phase I trial is studying the side effects and best dose of flavopiridol in treating patients with locally advanced or metastatic solid tumors.

OBJECTIVES:

Primary

  • Determine the toxicity profile and dose-limiting toxicity of flavopiridol in patients with locally advanced or metastatic solid tumors.
  • Determine the maximum tolerated dose of this drug in these patients.

Secondary

  • Determine the pharmacokinetics and pharmacodynamics of this drug in these patients.
  • Determine the immunomodulatory effects of this drug in these patients.
  • Determine pharmacogenomics of this drug, using peripheral blood mononuclear cells, in patients who experience clinical response.

OUTLINE: This is a pilot, dose-escalation study.

Patients receive flavopiridol IV over 4½ hours once weekly in weeks 1-4. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving stable disease after 4 courses of therapy discontinue study treatment. Patients who achieve complete remission (CR) receive 1 additional course of therapy beyond documentation of CR.

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 of 3 or 2 of 6 patients experience dose-limiting toxicity. A total of 10 patients are treated at the MTD.

After completion of study treatment, patients are followed within 4 weeks.

PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study.

Phase I
Interventional
Treatment
Unspecified Adult Solid Tumor, Protocol Specific
Drug: alvocidib
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
25
 
November 2006   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed solid tumor

    • Locally advanced or metastatic disease for which curative treatment does not exist or is no longer effective
  • Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan

    • No previously irradiated* measurable lesion unless lesion demonstrates progressive disease OR there are other measurable lesions outside the irradiated* field
    • The following are not considered measurable disease:

      • Bone lesions
      • Leptomeningeal disease
      • Ascites
      • Pleural or pericardial effusion
      • Lymphangitis cutis/pulmonis
      • Abdominal masses that are not confirmed and followed by imaging techniques
      • Cystic lesions NOTE: *External beam radiotherapy
  • No uncontrolled brain metastases

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-1

Life expectancy

  • At least 6 months

Hematopoietic

  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3

Hepatic

  • AST and ALT ≤ 2.5 times upper limit of normal (ULN)
  • Bilirubin ≤ 1.5 times ULN

Renal

  • Creatinine ≤ 1.5 times ULN

Cardiovascular

  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No uncontrolled cardiac arrhythmia
  • No uncontrolled hypertension

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No history of allergic reaction attributed to compounds of similar chemical or biological composition to flavopiridol
  • No ongoing or active infection
  • No uncontrolled illness
  • No psychiatric illness or social situation that would preclude study compliance

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • More than 12 weeks since prior hepatic arterial chemoembolization
  • More than 4 weeks since prior systemic chemotherapy
  • No prior flavopiridol

Endocrine therapy

  • Not specified

Radiotherapy

  • See Disease Characteristics
  • More than 12 weeks since prior radioactive metaiodobenzylguanidine (MIBG)
  • More than 4 weeks since prior external beam radiotherapy

Surgery

  • Not specified

Other

  • Recovered from all prior tumor-specific therapy
  • More than 4 weeks since prior investigational tumor-specific therapy
  • Concurrent octreotide for control of carcinoid syndrome allowed
  • No concurrent combination anti-retroviral therapy for HIV-positive patients
  • No other concurrent tumor-specific therapy
  • No other concurrent investigational therapy
  • No other concurrent anticancer therapy
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00112684
 
CDR0000429582, OSU-04111, OSU-2005C0009, NCI-7204
Arthur G. James Cancer Hospital & Richard J. Solove Research Institute
National Cancer Institute (NCI)
Study Chair: Manisha H. Shah, MD Arthur G. James Cancer Hospital & Richard J. Solove Research Institute
National Cancer Institute (NCI)
January 2008

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