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Flavopiridol, Gemcitabine, and Irinotecan in Treating Patients With Unresectable or Metastatic Solid Tumors Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or professional assistance by using a genuine doctor. We aren't mDs. Always consult your physician about Flavopiridol, Gemcitabine, and Irinotecan in Treating Patients With Unresectable or Metastatic Solid Tumors conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Flavopiridol, Gemcitabine, and Irinotecan in Treating Patients With Unresectable or Metastatic Solid Tumors Clinical research trials and Flavopiridol, Gemcitabine, and Irinotecan in Treating Patients With Unresectable or Metastatic Solid Tumors health trials occur in a lot of of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the potency of new does drugs. The role of the studies / undertakings is to figure out specific human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Flavopiridol, Gemcitabine, and Irinotecan in Treating Patients With Unresectable or Metastatic Solid Tumors. Flavopiridol, Gemcitabine, and Irinotecan in Treating Patients With Unresectable or Metastatic Solid Tumors Clinical Trials and other clinical trials permit volunteers to get medical treatment choices before they are available to the general public. Many times the test subjects get professional assistance for free of charge, and occasionally they are compensated for their time. Sometimes there is a cost for a Flavopiridol, Gemcitabine, and Irinotecan in Treating Patients With Unresectable or Metastatic Solid Tumors clinical trial. Human subjects often get the best healthcare possible for their Flavopiridol, Gemcitabine, and Irinotecan in Treating Patients With Unresectable or Metastatic Solid Tumors condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, medical hazards (perhaps life-threatening), and/or the treatment being ineffectual. Trials are federally governed with exacting guidelines to protect clinical trials patients.
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Home > "F" Clinical Trials Conditions > Flavopiridol, Gemcitabine, and Irinotecan in Treating Patients With Unresectable or Metastatic Solid Tumors  Flavopiridol, Gemcitabine, and Irinotecan in Treating Patients With Unresectable or Metastatic Solid Tumors
Flavopiridol, Gemcitabine, and Irinotecan in Treating Patients With Unresectable or Metastatic Solid Tumors
For Condition: unspecified adult solid tumor, protocol specific
Status: Recruiting
Sponsor(s): University of New Mexico , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy, such as flavopiridol, gemcitabine, and irinotecan, work in 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 gemcitabine and irinotecan in treating patients who have unresectable or metastaticsolid tumors.
Details: OBJECTIVES: Primary - Determine the maximum tolerated dose and recommended phase II dose of flavopiridol in combination with gemcitabine and irinotecan in patients with unresectable or metastatic solid tumors. - Determine the toxicity profile of this regimen in these patients. OUTLINE: This is a dose-escalation study of flavopiridol. Patients receive gemcitabine IV over 30 minutes followed by irinotecan IV over 30 minutes on days 1 and 8. Patients also receive flavopiridol IV over 60 minutes on days 2 and 9. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. 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. PROJECTED ACCRUAL: A total of 3-24 patients will be accrued for this study within 8-12 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed solid tumor that is metastatic or unresectable - Standard curative or palliative measures do not exist or are no longer effective - No known brain metastases PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 OR - Karnofsky 60-100% Life expectancy - More than 12 weeks Hematopoietic - WBC 3,000/mm^3 - Absolute neutrophil count 1,500/mm^3 - Platelet count 100,000/mm^3 Hepatic - Bilirubin normal - AST and ALT 2.5 times upper limit of normal Renal - Creatinine normal OR - Creatinine clearance 60 mL/min Cardiovascular - No venous thrombosis within the past 6 months - No thrombotic cerebrovascular accident within the past 6 months - No myocardial infarction within the past 6 months - No symptomatic congestive heart failure - No unstable angina pectoris - No cardiac arrhythmia Other - No ongoing or active infection - No prior allergic reaction attributed to compounds of similar chemical or biological composition to study agents - No other concurrent uncontrolled medical condition that would preclude study participation - No psychiatric illness or social situation that would preclude study participation - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy - Prior biologic therapy allowed Chemotherapy - More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered Endocrine therapy - Prior endocrine therapy allowed Radiotherapy - More than 4 weeks since prior radiotherapy and recovered Surgery - Prior surgery allowed Other - No other concurrent investigational agents - No concurrent combination antiretroviral therapy for HIV-positive patients
Total Enrollment:
Location and Contact Information:
Overall Study Official:
IanRabinowitz, Study Chair, University of New Mexico
University of New Mexico Cancer Research and Treatment Center *Recruiting*
Albuquerque, New Mexico, 87131-5636
United States
Recruiting Ian Rabinowitz 505-272-4551
Additional Information:
Study ID Numbers: CDR0000355358; UNM-0903C,NCI-6415
Study Start Date:
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00079352
Other Unspecified Adult Solid Tumor, Protocol Specific Studies:
1. Combination Chemotherapy in Treating Patients With Metastatic or Unresectable Solid Tumors
2. Soblidotin and Gemcitabine in Treating Patients With Locally Advanced or Metastatic Solid Tumors
3. Megestrol and Exercise in Treating Patients With Cancer-Related Weight Loss
4. Bupropion and Counseling With or Without Contigency Management to Enhance Smoking Cessation in Treating Cancer Survivors Who Continue to Smoke
5. Topotecan Plus Sargramostim in Treating Patients With Advanced Cancer
Related Studies:
Other unspecified adult solid tumor, protocol specific Clinical Trials
Other New Mexico Clinical Trials
Other Albuquerque Clinical Trials
Flavopiridol, Gemcitabine, and Irinotecan in Treating Patients With Unresectable or Metastatic Solid Tumors
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