Cisplatin, Doxorubicin and Tamoxifen in the Treatment of Incurable Soft Tissue and Endocrine Malignancies
cisplatin
+ doxorubicin hydrochloride
+ tamoxifen citrate
Adenocarcinoma+66
+ Adenocarcinoma, Papillary
+ Adenoma
Treatment Study
Summary
Study start date: May 1, 1994
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.30 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Until 65 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Ottawa Regional Cancer Centre at Ottawa Hospital - General Campus
Ottawa, CanadaOpen Ottawa Regional Cancer Centre at Ottawa Hospital - General Campus in Google Maps