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Combination Chemotherapy and Tamoxifen in Treating Patients With Solid Tumors Clinical Trials References presented on Clinical Trials Search is not intended to be a substitute for proven healthcare advice, trips or professional assistance by using a real medical. We aren't mDs. Always confer with your physician about Combination Chemotherapy and Tamoxifen in Treating Patients With Solid Tumors conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Combination Chemotherapy and Tamoxifen in Treating Patients With Solid Tumors Clinical research trials and Combination Chemotherapy and Tamoxifen in Treating Patients With Solid Tumors medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectualness of new does drugs. The purpose of the studies / projects is to solve specific human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to discover treatments for all sorts of conditions, such as Combination Chemotherapy and Tamoxifen in Treating Patients With Solid Tumors. Combination Chemotherapy and Tamoxifen in Treating Patients With Solid Tumors Clinical Trials and other clinical trials permit volunteers to access healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for without cost, and every now and again they are compensated for their time. Sometimes there is a cost for a Combination Chemotherapy and Tamoxifen in Treating Patients With Solid Tumors clinical trial. Subjects often receive the most expert healthcare possible for their Combination Chemotherapy and Tamoxifen in Treating Patients With Solid Tumors condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, healthcare dangers (perhaps life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with stern guidelines to protect clinical trials subjects.
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Home > "C" Clinical Trials Conditions > Combination Chemotherapy and Tamoxifen in Treating Patients With Solid Tumors  Combination Chemotherapy and Tamoxifen in Treating Patients With Solid Tumors
Combination Chemotherapy and Tamoxifen in Treating Patients With Solid Tumors
For Condition: Cancer
Status: Recruiting
Sponsor(s): Ottawa Regional Cancer Centre ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Estrogen can stimulate the growth of tumor cells. Hormone therapy using tamoxifen may fight cancer by blocking the uptake of estrogen. Combining tamoxifen and chemotherapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy consisting of cisplatin and doxorubicin plus tamoxifen in treating patients who have solid tumors.
Details: OBJECTIVES: - Determine the feasibility and efficacy of cisplatin, doxorubicin, and tamoxifen (CAT) in patients with soft tissue sarcoma, glioma, mesothelioma, hepatoma, thyroid cancer, or adrenal cancer. - Determine the toxicity of this regimen in these patients. OUTLINE: Patients receive cisplatin IV over 1-2 hours followed immediately by doxorubicin IV over 15-30 minutes on days 1-3 and oral tamoxifen twice daily on days 4-17. Treatment continues every 3 weeks in the absence of the total cumulative doxorubicin dose reaching at least 500 mg/m2, disease progression, or unacceptable toxicity. Patients who achieve partial remission (PR) undergo local surgery or radiotherapy, if feasible, to convert PR to complete remission. Patients are followed every 2 months for 1 year and then every 3 months for 2 years. PROJECTED ACCRUAL: A total of 14-30 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /65 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically proven soft tissue sarcoma, glioma, mesothelioma, hepatoma, thyroid cancer, or adrenal cancer with clinical, radiological, or histologic evidence of incurability - Patients with thyroid cancer must have failed radioactive iodine - Measurable or evaluable disease PATIENT CHARACTERISTICS: Age: - 65 and under Performance status: - ECOG 0-2 Hematopoietic: - Granulocyte count at least 1,500/mm3 - Platelet count at least 140,000/mm3 Hepatic: - Bilirubin normal Renal: - Creatinine less than 1.47 mg/dL Cardiovascular: - Left ventricular ejection fraction at least 50% by MUGA scan - No congestive heart failure - No severe, uncontrolled hypertension - No ischemia, life-threatening arrhythmia, or conduction disturbance by ECG Other: - No allergy to study medications - No uncontrolled infection - No active abuse of ethanol that would preclude treatment - No other prior or concurrent malignancy - Not pregnant - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - No more than 1 prior chemotherapy regimen - No prior anthracycline or cisplatin - At least 3 weeks since other prior chemotherapy and recovered Endocrine therapy: - Not specified Radiotherapy: - See Disease Characteristics - No prior radiotherapy to more than 25% of bone marrow - At least 3 weeks since other prior radiotherapy and recovered Surgery: - Not specified
Total Enrollment:
Location and Contact Information:
Overall Study Official:
StanGertler, Study Chair, Ottawa Regional Cancer Centre
Ottawa Regional Cancer Centre *Recruiting*
Ottawa, Ontario, K1H 1C4
Canada
Recruiting Stan Gertler 613-737-7700 ext. 56764
Additional Information:
Study ID Numbers: CDR0000063892; CAN-OTT-9401,NCI-V94-0566
Study Start Date:
Record last reviewed: March 2001
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002608
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Combination Chemotherapy and Tamoxifen in Treating Patients With Solid Tumors
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