Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Combination Chemotherapy and Tamoxifen in Treating Patients With Solid Tumors

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Completed 65 and under Other CAN-OTT-9401 NCI-V94-0566, NCT00002608

Objectives

1. 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.
2. Determine the toxicity of this regimen in these patients.

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

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

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

Expected Enrollment

A total of 14-30 patients will be accrued for this study.

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.

Gertler SZ, Yau J, Stewart DJ, et al.: Cisplatin, doxorubicin and tamoxifen (CAT) in the treatment of incurable soft tissue and endocrine malignancies-preliminary results. [Abstract] Proceedings of the American Society of Clinical Oncology 15: A1427, 1996.

Trial Contact Information

Trial Lead Organizations

Ottawa Hospital Regional Cancer Centre - General Campus

Stan Gertler, MD, FRCPC, Protocol chair		Ph: 613-737-7700 ext. 70209; 888-627-5346

Registry Information
Official Title		Cisplatin, Doxorubicin and Tamoxifen in the Treatment of Incurable Soft Tissue and Endocrine Malignancies
Trial Start Date		1994-05-11
Registered in ClinicalTrials.gov		NCT00002608
Date Submitted to PDQ		1994-05-11
Information Last Verified		2005-05-16

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