Combination Chemotherapy and Tamoxifen in Treating Patients With Solid Tumors

Ottawa Regional Cancer Centre

Status and phase: Completed; Phase 2

Conditions: Malignant Mesothelioma; Sarcoma; Brain and Central Nervous System Tumors; Adrenocortical Carcinoma; Head and Neck Cancer; Liver Cancer; Pheochromocytoma

Treatments: Radiation: radiation therapy; Drug: doxorubicin hydrochloride; Drug: tamoxifen citrate; Drug: cisplatin; Procedure: conventional surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT00002608

CDR0000063892 (Registry Identifier)

CAN-OTT-9401

NCI-V94-0566

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: Under 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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