Official Title: “Cisplatin, Doxorubicin and Tamoxifen in the Treatment of Incurable Soft Tissue and Endocrine Malignancies”

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.

Study Type: Interventional

Study Design: Treatment, Open Label

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.

Intervention(s) in this Clinical Trial

• Drug: cisplatin
• Drug: doxorubicin hydrochloride
• Drug: tamoxifen citrate
• Procedure: conventional surgery
• Procedure: radiation therapy

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 Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Ottawa Hospital Regional Cancer Centre - General Campus

Overall Clinical Trial Officials and Contacts

Stan Z. Gertler, MD, FRCPC Study Chair Ottawa Hospital Regional Cancer Centre - General Campus  

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00002608

Study ID Number: CDR0000063892

ClinicalTrials.gov Identifier: NCT00002608

Health Authority: United States: Federal Government

Clinical trial summary from the National Cancer Institute's PDQ® database