Combination Chemotherapy and Tamoxifen in Treating Patients With Solid Tumors

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

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

Intervention / Treatment
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* Drug: cisplatin
* Drug: doxorubicin hydrochloride
* Drug: tamoxifen citrate
* Procedure: conventional surgery
* Radiation: radiation therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: cisplatin|nan|
|Drug: doxorubicin hydrochloride|nan|
|Drug: tamoxifen citrate|nan|
|Procedure: conventional surgery|nan|
|Radiation: radiation therapy|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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childhood brain tumor, childhood infratentorial ependymoma, childhood supratentorial ependymoma, recurrent adult soft tissue sarcoma, recurrent childhood brain tumor, childhood liver cancer, stage IV childhood liver cancer, recurrent childhood liver cancer, advanced malignant mesothelioma, recurrent malignant mesothelioma, localized unresectable adult primary liver cancer, advanced adult primary liver cancer, recurrent adult primary liver cancer, recurrent adult brain tumor, stage IV adrenocortical carcinoma, recurrent adrenocortical carcinoma, stage IV papillary thyroid cancer, stage IV follicular thyroid cancer, thyroid gland medullary carcinoma, anaplastic thyroid cancer, recurrent thyroid cancer, adult brain stem glioma, adult medulloblastoma, adult glioblastoma, metastatic pheochromocytoma, recurrent pheochromocytoma, childhood soft tissue sarcoma, metastatic childhood soft tissue sarcoma, recurrent childhood soft tissue sarcoma, childhood high-grade cerebral astrocytoma, childhood oligodendroglioma, adult anaplastic astrocytoma, adult myxopapillary ependymoma, adult anaplastic ependymoma, adult anaplastic oligodendroglioma, adult mixed glioma, adult pilocytic astrocytoma, adult subependymoma, recurrent childhood brain stem glioma, recurrent childhood cerebellar astrocytoma, recurrent childhood cerebral astrocytoma, recurrent childhood medulloblastoma, recurrent childhood visual pathway and hypothalamic glioma, recurrent childhood ependymoma, stage IV adult soft tissue sarcoma, adult oligodendroglioma, adult giant cell glioblastoma, adult gliosarcoma, adult diffuse astrocytoma