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

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.


Condition Intervention Phase
Unspecified Adult Solid Tumor, Protocol Specific
Drug: alvocidib
Drug: gemcitabine hydrochloride
Phase I

MedlinePlus related topics: Cancer
Drug Information available for: Gemcitabine Gemcitabine hydrochloride Alvocidib Flavopiridol
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: A Phase I Trial Of Gemcitabine Followed By Flavopiridol In Patients With Solid Tumors

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: January 2001
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00007917

Locations
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Dana-Farber Cancer Institute
Investigators
Study Chair: Geoffrey Shapiro, MD, PhD Dana-Farber Cancer Institute
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000068344, DFCI-00166, NCI-24
Study First Received: January 6, 2001
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00007917     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
unspecified adult solid tumor, protocol specific

Study placed in the following topic categories:
Antimetabolites
Flavopiridol
Radiation-Sensitizing Agents
Immunologic Factors
Gemcitabine
Protein Kinase Inhibitors
Immunosuppressive Agents
Antiviral Agents

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Enzyme Inhibitors
Protein Kinase Inhibitors
Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Flavopiridol
Radiation-Sensitizing Agents
Therapeutic Uses
Growth Inhibitors
Gemcitabine

ClinicalTrials.gov processed this record on May 06, 2009