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Combination Chemotherapy and Tamoxifen in Treating Patients With Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00002608
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : July 10, 2013
Information provided by:
National Cancer Institute (NCI)

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.

Condition or disease Intervention/treatment 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

Detailed Description:


  • 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cisplatin, Doxorubicin and Tamoxifen in the Treatment of Incurable Soft Tissue and Endocrine Malignancies
Study Start Date : May 1994
Actual Study Completion Date : April 2005

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • 65 and under

Performance status:

  • ECOG 0-2


  • Granulocyte count at least 1,500/mm3
  • Platelet count at least 140,000/mm3


  • Bilirubin normal


  • Creatinine less than 1.47 mg/dL


  • 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


  • 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


Biologic therapy:

  • Not specified


  • 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


  • See Disease Characteristics
  • No prior radiotherapy to more than 25% of bone marrow
  • At least 3 weeks since other prior radiotherapy and recovered


  • Not specified

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00002608

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Canada, Ontario
Ottawa Regional Cancer Centre at Ottawa Hospital - General Campus
Ottawa, Ontario, Canada, K1H 1C4
Sponsors and Collaborators
Ottawa Regional Cancer Centre
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Study Chair: Stan Z. Gertler, MD, FRCPC Ottawa Regional Cancer Centre
Publications of Results:
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.

Layout table for additonal information Identifier: NCT00002608    
Other Study ID Numbers: CAN-OTT-9401
CDR0000063892 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: July 10, 2013
Last Verified: May 2005
Keywords provided by National Cancer Institute (NCI):
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
Additional relevant MeSH terms:
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Liver Neoplasms
Nervous System Neoplasms
Central Nervous System Neoplasms
Adrenocortical Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Connective and Soft Tissue
Neoplasms by Site
Digestive System Neoplasms
Digestive System Diseases
Liver Diseases
Neoplasms, Mesothelial
Nervous System Diseases
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Adrenal Cortex Neoplasms
Adrenal Gland Neoplasms
Endocrine Gland Neoplasms
Adrenal Cortex Diseases
Adrenal Gland Diseases