Clinical trial NCT00002608: Combination Chemotherapy and Tamoxifen in Treating Patients With Solid Tumors
Official title: Cisplatin, Doxorubicin and Tamoxifen in the Treatment of Incurable Soft Tissue and Endocrine Malignancies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Adrenocortical Carcinoma
Brain and Central Nervous System Tumors
Head and Neck Cancer
Liver Cancer
Malignant Mesothelioma
Pheochromocytoma
Sarcoma
Keywords: 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
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2003-01-27
Enrollment: 30
Sex: ALL
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: Ottawa Regional Cancer Centre at Ottawa Hospital - General Campus
state: Ontario
Study officials:
affiliation: Ottawa Regional Cancer Centre
name: Stan Z. Gertler, MD, FRCPC
role: STUDY_CHAIR
References:
citation: 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.