Combination Chemotherapy and Tamoxifen in Treating Patients With Solid Tumors
Launched by OTTAWA REGIONAL CANCER CENTRE · Jan 26, 2003
Trial Information
Current as of March 16, 2025
Completed
Keywords
ClinConnect Summary
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 toxic...
Gender
ALL
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
Trial Officials
Stan Z. Gertler, MD, FRCPC
Study Chair
Ottawa Regional Cancer Centre
About Ottawa Regional Cancer Centre
The Ottawa Regional Cancer Centre (ORCC) is a leading clinical research institution dedicated to advancing cancer care and treatment through innovative research and clinical trials. As a prominent sponsor of oncology studies, ORCC focuses on developing and evaluating new therapeutic strategies, enhancing patient outcomes, and contributing to the global understanding of cancer. With a multidisciplinary team of experts and a commitment to patient-centered research, the ORCC strives to bridge the gap between laboratory discoveries and clinical applications, ensuring that cutting-edge treatments are accessible to patients in the Ottawa region and beyond.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Ottawa, Ontario, Canada
People applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Discussion 0
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