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Combination Chemotherapy and Tamoxifen in Treating Patients With Solid Tumors

This study has been completed.

Sponsored by: Ottawa Hospital Regional Cancer Centre - General Campus
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00002608
  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
Procedure: radiation therapy
Phase II

MedlinePlus related topics:   Brain Cancer    Cancer    Childhood Brain Tumors    Head and Neck Cancer    Liver Cancer    Mesothelioma    Pheochromocytoma    Soft Tissue Sarcoma    Thyroid Cancer   

ChemIDplus related topics:   Doxorubicin    Doxorubicin hydrochloride    Cisplatin    Tamoxifen    Tamoxifen citrate    Citric acid    Sodium Citrate    Thyroid   

U.S. FDA Resources

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

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

Estimated Enrollment:   30
Study Start Date:   May 1994

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 Hospital Regional Cancer Centre - General Campus

Investigators
Study Chair:     Stan Z. Gertler, MD, FRCPC     Ottawa Hospital Regional Cancer Centre - General Campus    
  More Information

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

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.

Study ID Numbers:   CDR0000063892, CAN-OTT-9401, NCI-V94-0566
First Received:   November 1, 1999
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00002608
Health Authority:   United States: Federal Government

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

Study placed in the following topic categories:
Glioblastoma
Liver Diseases
Malignant mesenchymal tumor
Adrenocortical carcinoma
Adrenal Gland Diseases
Central Nervous System Neoplasms
Neoplasms, Connective and Soft Tissue
Neuroepithelioma
Glioma
Adrenal Cortex Neoplasms
Nervous System Neoplasms
Endocrine Gland Neoplasms
Digestive System Neoplasms
Astrocytoma
Citric Acid
Endocrine System Diseases
Tamoxifen
Doxorubicin
Carcinoma
Thyroid cancer, papillary
Brain Neoplasms
Neuroectodermal Tumors
Sarcoma
Gastrointestinal Neoplasms
Adrenal Cortex Diseases
Thyroid cancer, follicular
Neoplasms, Glandular and Epithelial
Liver neoplasms
Ependymoma
Pheochromocytoma

Additional relevant MeSH terms:
Estrogen Antagonists
Neoplasms by Histologic Type
Antineoplastic Agents, Hormonal
Neoplasms, Mesothelial
Antineoplastic Agents
Hormone Antagonists
Nervous System Diseases
Neoplasms, Nerve Tissue
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Bone Density Conservation Agents
Selective Estrogen Receptor Modulators
Antibiotics, Antineoplastic
Pharmacologic Actions
Estrogen Receptor Modulators
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 05, 2008




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