Combination Chemotherapy and Tamoxifen in Treating Patients With Solid Tumors - Full Text View

Purpose

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.

Condition	Intervention	Phase
Adrenocortical Carcinoma Brain and Central Nervous System Tumors Head and Neck Cancer Liver Cancer Malignant Mesothelioma Pheochromocytoma Sarcoma	Drug: cisplatin Drug: doxorubicin hydrochloride Drug: tamoxifen citrate Procedure: conventional surgery Radiation: radiation therapy	Phase 2

Study Type:	Interventional
Study Design:	Masking: Open Label Primary Purpose: Treatment
Official Title:	Cisplatin, Doxorubicin and Tamoxifen in the Treatment of Incurable Soft Tissue and Endocrine Malignancies

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment:	30
Study Start Date:	May 1994
Study Completion Date:	April 2005

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

Ages Eligible for Study:	up to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002608

Locations

Canada, Ontario
Ottawa Regional Cancer Centre at Ottawa Hospital - General Campus
Ottawa, Ontario, Canada, K1H 1C4

Sponsors and Collaborators

Ottawa Regional Cancer Centre

Investigators

Study Chair:

Stan Z. Gertler, MD, FRCPC

Ottawa Regional Cancer Centre

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

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.

ClinicalTrials.gov Identifier:	NCT00002608 History of Changes
Other Study ID Numbers:	CAN-OTT-9401, CDR0000063892, NCI-V94-0566
Study First Received:	November 1, 1999
Last Updated:	May 21, 2013
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

adult anaplastic ependymoma
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

Additional relevant MeSH terms:

Carcinoma
Head and Neck Neoplasms
Liver Neoplasms
Mesothelioma
Nervous System Neoplasms
Pheochromocytoma
Central Nervous System Neoplasms
Adrenocortical Carcinoma
Sarcoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site
Digestive System Neoplasms
Digestive System Diseases

Liver Diseases
Adenoma
Neoplasms, Mesothelial
Nervous System Diseases
Paraganglioma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Adenocarcinoma
Adrenal Cortex Neoplasms
Adrenal Gland Neoplasms
Endocrine Gland Neoplasms
Adrenal Cortex Diseases
Adrenal Gland Diseases

ClinicalTrials.gov processed this record on May 21, 2013