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Irinotecan and Gemcitabine in Treating Patients With Refractory Advanced Solid Tumors Clinical Trials Info presented on Clinical Trials Search is not intended to be a substitute for certified medical advice, visits or professional assistance using a real physician. We are not physicians. Always consult your dr. about Irinotecan and Gemcitabine in Treating Patients With Refractory Advanced Solid Tumors conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Irinotecan and Gemcitabine in Treating Patients With Refractory Advanced Solid Tumors Clinical research trials and Irinotecan and Gemcitabine in Treating Patients With Refractory Advanced Solid Tumors health trials happen in many of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new drugs. The function of the studies / projects is to resolve particular human medical questions. Clinical trials are a popular manner for mDs, government agencies, and private sector corporations to discover remedies for all varieties of circumstances, like Irinotecan and Gemcitabine in Treating Patients With Refractory Advanced Solid Tumors. Irinotecan and Gemcitabine in Treating Patients With Refractory Advanced Solid Tumors Clinical Trials and other clinical trials allow volunteers to obtain healthcare treatment options before they are available to the masses. Some times the participants undergo professional assistance for free of charge, and occasionally they are paid for their time. Sometimes there is a cost for a Irinotecan and Gemcitabine in Treating Patients With Refractory Advanced Solid Tumors clinical trial. Human subjects often get the best healthcare available for their Irinotecan and Gemcitabine in Treating Patients With Refractory Advanced Solid Tumors condition. Dangers are a reality, however, and may include additional or frequent mD visits, healthcare dangers (potentially life-jeopardising), and/or the treatment being ineffectual. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "I" Clinical Trials Conditions > Irinotecan and Gemcitabine in Treating Patients With Refractory Advanced Solid Tumors  Irinotecan and Gemcitabine in Treating Patients With Refractory Advanced Solid Tumors
Irinotecan and Gemcitabine in Treating Patients With Refractory Advanced Solid Tumors
For Condition: unspecified adult solid tumor, protocol specific
Status: No longer recruiting
Sponsor(s): Roswell Park Cancer Institute , National Cancer Institute (NCI)
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 combining irinotecan with gemcitabine in treating patients who have refractory advanced solid tumors.
Details: OBJECTIVES: - Determine the maximum tolerated dose of irinotecan when administered with gemcitabine in patients with refractory advanced solid tumors. - Determine the antitumor activity and toxicity of this regimen in these patients. - Determine the pharmacokinetics and pharmacodynamics of this regimen in these patients. - Determine the optimal dose and time interval for this regimen in these patients. OUTLINE: This is an open-label, non-randomized, dose-escalation study of irinotecan. Patients receive irinotecan IV over 90 minutes on days 1 and 8 and gemcitabine IV over 30 minutes 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 irinotecan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Patients are followed every 8 weeks. PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study within 2 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed advanced solid tumor that is refractory to prior treatment - Considered incurable with other modalities - Measurable or evaluable disease - The following are not considered measurable or evaluable: - Bone metastases - Pleural, pericardial, or peritoneal effusions - Irradiated lesions (unless progression is documented after radiotherapy) - Metastatic disease that has been followed using serum tumor markers allowed - No symptomatic brain metastases - Brain metastases may not be sole site of metastatic disease PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-1 Life expectancy - At least 12 weeks Hematopoietic - WBC at least 3,000/mm^3 - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic - AST and ALT no greater than 1.5 times normal - Bilirubin no greater than 1.5 mg/dL - No clinically apparent jaundice Renal - Creatinine no greater than 1.6 mg/dL OR - Creatinine clearance at least 50 mL/min Cardiovascular - Cardiac function normal - No uncontrolled heart disease - No myocardial infarction within the past 3 months - No congestive heart failure - No unstable or uncontrolled angina Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix - No active infection requiring systemic therapy - No uncontrolled seizures - No uncontrolled diabetes mellitus PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - No prior gemcitabine - No prior camptothecin compounds - Prior irinotecan allowed - No other concurrent chemotherapy Endocrine therapy - Not specified Radiotherapy - See Disease Characteristics - At least 14 days since prior radiotherapy - No concurrent radiotherapy Surgery - Not specified Other - More than 30 days since prior clinical trial participation - No other concurrent investigational medications
Total Enrollment:
Location and Contact Information:
Overall Study Official:
NithyaRamnath, Study Chair, Roswell Park Cancer Institute
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
United States
Additional Information:
Study ID Numbers: CDR0000270343; RPCI-DS-01-18
Study Start Date:
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00054288
Other Unspecified Adult Solid Tumor, Protocol Specific Studies:
1. Mistletoe Lectin in Treating Patients With Advanced Solid Tumors That Have Not Responded to Previous Therapy
2. Irinotecan Plus ICI D1694 in Treating Patients With Advanced Solid Tumors
3. Flavopiridol, Oxaliplatin, Fluorouracil, and Leucovorin in Treating Patients With Advanced Solid Tumors
4. 3-AP Plus Cisplatin and Paclitaxel in Treating Patients With Advanced or Metastatic Cancer
5. Combination Chemotherapy in Treating Patients With Advanced Cancer
Related Studies:
Other unspecified adult solid tumor, protocol specific Clinical Trials
Other New York Clinical Trials
Other Buffalo Clinical Trials
Irinotecan and Gemcitabine in Treating Patients With Refractory Advanced Solid Tumors
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