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Ro 31-7453 in Treating Patients With 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 treatment with a real dr.. We aren't doctors. Always consult your mD on Ro 31-7453 in Treating Patients With Metastatic Solid Tumors conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Ro 31-7453 in Treating Patients With Metastatic Solid Tumors Clinical research trials and Ro 31-7453 in Treating Patients With Metastatic Solid Tumors medical trials occur in many of places across the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectiveness of new does drugs. The role of the studies / undertakings is to figure out certain human healthcare questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to locate treatments for all forms of circumstances, including Ro 31-7453 in Treating Patients With Metastatic Solid Tumors. Ro 31-7453 in Treating Patients With Metastatic Solid Tumors Clinical Trials and other clinical trials permit volunteers to get medical treatment options before they are available to the masses. Most times the human subjects acquire treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Ro 31-7453 in Treating Patients With Metastatic Solid Tumors clinical trial. Participants oftentimes recieve the finest healthcare available for their Ro 31-7453 in Treating Patients With Metastatic Solid Tumors condition. Dangers are a reality, nonetheless, and might include extra or frequent physician calls, health hazards (potentially life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "R" Clinical Trials Conditions > Ro 31-7453 in Treating Patients With Metastatic Solid Tumors  Ro 31-7453 in Treating Patients With Metastatic Solid Tumors
Ro 31-7453 in Treating Patients With Metastatic Solid Tumors
For Condition: unspecified adult solid tumor, protocol specific
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Memorial Sloan-Kettering Cancer Center
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Randomized phase I trial to determine if Ro 31-7453 is more effective with or without food in treating patients who have metastatic solid tumors.
Details: OBJECTIVES: I. Assess the impact of food on the bioavailability of Ro 31-7453 in patients with locally advanced or metastatic solid tumors. PROTOCOL OUTLINE: This is a randomized crossover study. Patients are randomized to one of two treatment arms. Arm I: Patients receive oral Ro 31-7453 under fasting conditions on day 1. After a 1 week washout period, patients receive oral Ro 31-7453 under fed conditions. Arm II: Patients receive fed treatment as in arm I on day 1. After a 1 week washout period, patients receive fasted treatment as in arm I. Both arms: At the start of week 3, patients may continue to receive oral Ro 31-7453 every 12 hours on days 1-4. Treatment repeats every 3 weeks for at least 24 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed at 7 days. PROJECTED ACCRUAL: A total of 10 patients (5 per arm) 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 or cytologically confirmed locally advanced or metastatic solid tumor for which no standard therapy is available - No CNS metastases --Prior/Concurrent Therapy-- - Biologic therapy: At least 3 weeks since prior biologic therapy - Chemotherapy: At least 3 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas) - Endocrine therapy: At least 2 weeks since prior endocrine therapy (except for antiandrogen therapy); Concurrent antiandrogen therapy allowed; Concurrent corticosteroids allowed if receiving stable dose for at least 2 weeks prior to study - Radiotherapy: At least 3 weeks since prior radiotherapy - Surgery: - Other: No prior enrollment in this study; At least 4 weeks since prior investigational drugs; No other concurrent investigational agents --Patient Characteristics-- - Age: 18 and over - Performance status: Karnofsky 60-100% - Life expectancy: Not specified - Hematopoietic: Hemoglobin at least 9 g/dL; WBC at least 3,000/mm3; Absolute neutrophil count at least 1,500/mm3; Platelet count at least 100,000/mm3 - Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN); AST and ALT no greater than 2.5 times ULN (4 times ULN if liver metastases present); Alkaline phosphatase no greater than 2.5 times ULN (4 times ULN if liver or bone metastases present) - Renal: Creatinine no greater then 1.5 times ULN - Cardiovascular: No history or clinical signs of significant cardiovascular disease - Other: No other serious concurrent illness; No neuropathy greater than grade II; No evidence of gastrointestinal dysfunction; No intolerance to a high fat meal; Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception
Total Enrollment:
Location and Contact Information:
Overall Study Official:
StevenSoignet, Study Chair, Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
Additional Information:
Study ID Numbers: CDR0000068537; ROCHE-NP15980C,NCI-G01-1928,MSKCC-00118
Study Start Date: October 2000
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00014365
Other Unspecified Adult Solid Tumor, Protocol Specific Studies:
1. Vaccine Therapy in Treating Patients With Refractory Stage IV Cancer
2. S-3304 in Treating Patients With Advanced Solid Tumors
3. Neoadjuvant Tipifarnib, Docetaxel, and Capecitabine in Treating Patients With Locally Advanced or Metastatic Solid Tumors or Stage IIIA or Stage IIIB Breast Cancer
4. CP-609,754 in Treating Patients With Advanced Solid Tumors
5. Etanercept in Treating Cancer-Related Cachexia and Anorexia in Patients With Advanced Cancer
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Ro 31-7453 in Treating Patients With Metastatic Solid Tumors
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