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Combination Chemotherapy and Tamoxifen in Treating Patients With Solid Tumors

Descriptive Information
Brief Title † Combination Chemotherapy and Tamoxifen in Treating Patients With Solid Tumors
Official Title † Cisplatin, Doxorubicin and Tamoxifen in the Treatment of Incurable Soft Tissue and Endocrine Malignancies
Brief Summary RATIONALE: Drugs used in chemotherapy, such as cisplatin and doxorubicin, work in 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 with chemotherapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving cisplatin and doxorubicin together with tamoxifen works in treating patients with solid tumors.
Detailed Description 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.
Study Phase Phase 2
Study Type † Interventional
Study Design † Masking: Open Label, Primary Purpose: Treatment
Primary Outcome Measure †
Secondary Outcome Measure †
Condition † Adrenocortical Carcinoma Brain and Central Nervous System Tumors Head and Neck Cancer Liver Cancer Malignant Mesothelioma Pheochromocytoma Sarcoma
Intervention † Drugcisplatin
Study Arms / Comparison Groups
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Drug
Estimated Enrollment † 30
Start Date † May 1994
Completion Date April 2005
Primary Completion Date
Eligibility 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
Gender Both
Ages N/A - 65 Years
Accepts Healthy Volunteers No
Contacts ††
Location Countries † Canada
Administrative Information
NCT ID † NCT00002608
Organization ID CAN-OTT-9401
Secondary IDs †† CDR0000063892, NCI-V94-0566
Responsible Party
Study Sponsor † Ottawa Regional Cancer Centre
Collaborators ††
Investigators † Study Chair: Stan Z. Gertler, MD, FRCPC, Ottawa Regional Cancer Centre
Information Provided By
Verification Date May 2005
First Received Date † November 1, 1999
Last Updated Date July 9, 2013
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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