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Gemcitabine Plus Flavopiridol in Treating Patients With Advanced Solid Tumors
This study is ongoing, but not recruiting participants.
Study NCT00007917   Information provided by National Cancer Institute (NCI)
First Received: January 6, 2001   Last Updated: July 23, 2008   History of Changes

January 6, 2001
July 23, 2008
January 2001
 
 
 
Complete list of historical versions of study NCT00007917 on ClinicalTrials.gov Archive Site
 
 
 
Gemcitabine Plus Flavopiridol in Treating Patients With Advanced Solid Tumors
A Phase I Trial Of Gemcitabine Followed By Flavopiridol In Patients With 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 gemcitabine plus flavopiridol in treating patients who have advanced solid tumors.

OBJECTIVES:

  • Determine the maximum tolerated dose of gemcitabine and flavopiridol in patients with advanced solid tumors.
  • Determine the toxicity and safety profile of this regimen in these patients.
  • Determine the pharmacokinetic profile of this regimen in this patient population.

OUTLINE: This is a dose-escalation study.

Patients receive gemcitabine IV over 1-2.5 hours on days 1 and 8 and flavopiridol IV continuously over 24 hours on days 2 and 9. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of gemcitabine and flavopiridol until the maximum tolerated dose (MTD) is reached. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

PROJECTED ACCRUAL: Approximately 6-58 patients will be accrued for this study.

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

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
 
 
 

DISEASE CHARACTERISTICS:

  • Histologically proven solid tumor for which gemcitabine is a treatment option or for which no effective therapy exists
  • Previously untreated disease allowed
  • No large and potentially symptomatic pericardial effusion or undrained pleural effusion (with or without pleurodesis)
  • No CNS metastases

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • At least 12 weeks

Hematopoietic:

  • Absolute neutrophil count at least 2,000/mm3
  • Platelet count at least 100,000/mm3
  • No prior thrombotic events

Hepatic:

  • Bilirubin no greater than 1.5 mg/dL
  • SGOT no greater than 2 times upper limit of normal

Renal:

  • Creatinine no greater than 1.5 mg/dL

Cardiovascular:

  • No clinically significant cardiac disease
  • No prior deep venous thrombus
  • No prior arterial vascular event
  • No prior myocardial infarction
  • No unstable angina
  • No prior transient ischemic attack or cerebrovascular accident
  • No cardiac arrhythmias that could be related to cardiac ischemia

Pulmonary:

  • No clinically significant pulmonary disease
  • No history of pulmonary embolism

Other:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No active infection
  • No severe malnutrition or intractable emesis
  • No chronic diarrheal disease within the past 6 months

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • See Disease Characteristics
  • No more than 1 prior chemotherapy regimen
  • At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
  • Prior gemcitabine or flavopiridol allowed
  • No other concurrent chemotherapy

Endocrine therapy:

  • Not specified

Radiotherapy:

  • At least 3 weeks since prior radiotherapy and recovered
  • No prior radiotherapy to more than 50% of bone marrow
  • No concurrent radiotherapy

Surgery:

  • Not specified
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00007917
 
CDR0000068344, DFCI-00166, NCI-24
Dana-Farber Cancer Institute
National Cancer Institute (NCI)
Study Chair: Geoffrey Shapiro, MD, PhD Dana-Farber Cancer Institute
National Cancer Institute (NCI)
September 2002

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