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)

November 1, 1999
January 27, 2003
July 10, 2013
May 1994
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Complete list of historical versions of study NCT00002608 on Archive Site
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Combination Chemotherapy and Tamoxifen in Treating Patients With Solid Tumors
Cisplatin, Doxorubicin and Tamoxifen in the Treatment of Incurable Soft Tissue and Endocrine Malignancies

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.


  • 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.

Phase 2
Masking: None (Open Label)
Primary Purpose: Treatment
  • 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
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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.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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April 2005
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  • 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
Sexes Eligible for Study: All
up to 65 Years   (Child, Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
CDR0000063892 ( Registry Identifier: PDQ (Physician Data Query) )
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Ottawa Regional Cancer Centre
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Study Chair: Stan Z. Gertler, MD, FRCPC Ottawa Regional Cancer Centre
National Cancer Institute (NCI)
May 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP