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Home > "G" Clinical Trials Conditions > Gemcitabine Plus Flavopiridol in Treating Patients With Advanced Solid Tumors

Gemcitabine Plus Flavopiridol in Treating Patients With Advanced Solid Tumors



Gemcitabine Plus Flavopiridol in Treating Patients With Advanced Solid Tumors

For Condition: unspecified adult solid tumor, protocol specific
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Dana-Farber/Harvard Cancer Center
Synopsis: 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.
Details: OBJECTIVES: I. Determine the maximum tolerated dose of gemcitabine and flavopiridol in patients with advanced solid tumors. II. Determine the toxicity and safety profile of this regimen in these patients. III. Determine the pharmacokinetic profile of this regimen in this patient population. PROTOCOL 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:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: 
Protocol Entry Criteria: PROTOCOL ENTRY 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 --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 --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
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
GeoffreyShapiro,  Study Chair,  Dana-Farber/Harvard Cancer Center

Massachusetts General Hospital Cancer Center
Boston,  Massachusetts,  02114
United States
 

Dana-Farber Cancer Institute
Boston,  Massachusetts,  02115
United States
 


Additional Information:
Study ID Numbers:  CDR0000068344;  NCI-24,DFCI-00166
Study Start Date: January 2001
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00007917

Other Unspecified Adult Solid Tumor, Protocol Specific Studies:
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2. Radiofrequency Ablation in Treating Patients With Bone Metastases

3. KRN5500 in Treating Patients With Metastatic Solid Tumors

4. Continuous Infusion Gemcitabine in Treating Patients With Advanced Metastatic Cancer

5. UCN-01 and Cisplatin in Treating Patients With Advanced Solid Tumors

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