Cisplatin, Doxorubicin and Tamoxifen in the Treatment of Incurable Soft Tissue and Endocrine Malignancies
N/A
65 Years
Both
Adrenocortical Carcinoma, Brain and Central Nervous System Tumors, Head and Neck Cancer, Liver Cancer, Malignant Mesothelioma, Pheochromocytoma, Sarcoma
Trial Information
Cisplatin, Doxorubicin and Tamoxifen in the Treatment of Incurable Soft Tissue and Endocrine Malignancies
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Principal Investigator
Stan Z. Gertler, MD, FRCPC
Investigator Role:
Study Chair
Investigator Affiliation:
Ottawa Regional Cancer Centre
Authority:
United States: Federal Government
Study ID:
CAN-OTT-9401
NCT ID:
NCT00002608
Start Date:
May 1994
Completion Date:
April 2005
Related Keywords:
- Adrenocortical Carcinoma
- Brain and Central Nervous System Tumors
- Head and Neck Cancer
- Liver Cancer
- Malignant Mesothelioma
- Pheochromocytoma
- Sarcoma
- 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
- Carcinoma
- Head and Neck Neoplasms
- Liver Neoplasms
- Mesothelioma
- Nervous System Neoplasms
- Pheochromocytoma
- Central Nervous System Neoplasms
- Adrenocortical Carcinoma
- Sarcoma
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