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Combination Chemotherapy and Tamoxifen in Treating Patients With Solid Tumors

This study has been completed.
Study NCT00002608.   Last updated on July 23, 2008.   Information provided by National Cancer Institute (NCI)

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Descriptive Information Fields
Brief Title  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
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.

Study Phase Phase II
Study Type  Interventional
Study Design  Treatment, Open Label
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  Adrenocortical Carcinoma
Brain and Central Nervous System Tumors
Head and Neck Cancer
Liver Cancer
Malignant Mesothelioma
Pheochromocytoma
Sarcoma
Intervention  Drug: cisplatin
Drug: doxorubicin hydrochloride
Drug: tamoxifen citrate
Procedure: conventional surgery
Procedure: radiation therapy
MEDLINE PMIDs
Links Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status  Completed
Enrollment  30
Start Date  May 1994
Completion Date
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
Gender Both
Ages up to 65 Years
Accepts Healthy Volunteers No
Contacts ††
Location Countries  Canada
Administrative Information Fields
NCT ID  NCT00002608
Organization ID CDR0000063892
Secondary IDs †† CAN-OTT-9401, NCI-V94-0566
Study Sponsor  Ottawa Hospital Regional Cancer Centre - General Campus
Collaborators ††
Investigators 
Study Chair:     Stan Z. Gertler, MD, FRCPC     Ottawa Hospital Regional Cancer Centre - General Campus    
Information Provided By National Cancer Institute (NCI)
Verification Date May 2005
First Received Date  November 1, 1999
Last Updated Date July 23, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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