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Completed

NCT Number: NCT00002608

Combination Chemotherapy and Tamoxifen in Treating Patients With Solid Tumors

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.

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Key information

Conditions

Adrenocortical Carcinoma Adenocarcinoma Adenocarcinoma, Follicular Adenocarcinoma, Papillary Adenoma Adrenal Cortex Diseases Adrenal Cortex Neoplasms Adrenal Gland Diseases Adrenal Gland Neoplasms Astrocytoma Brain Diseases Brain Neoplasms Brain and Central Nervous System Tumors Carcinoma Carcinoma, Hepatocellular Carcinoma, Medullary Carcinoma, Neuroendocrine Central Nervous System Diseases Central Nervous System Neoplasms Cranial Nerve Diseases Cranial Nerve Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Ependymoma Eye Diseases Familial ependymoma Glioblastoma Glioma Glioma, Subependymal Gliosarcoma Head and Neck Cancer Head and Neck Neoplasms Liver Cancer Liver Diseases Liver Neoplasms Lung Diseases Lung Neoplasms Malignant Mesothelioma Medulloblastoma Mesothelioma Mesothelioma, Malignant Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Connective and Soft Tissue Neoplasms, Ductal, Lobular, and Medullary Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Mesothelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Nervous System Diseases Nervous System Neoplasms Neuroectodermal Tumors Neuroectodermal Tumors, Primitive Neuroendocrine Tumors Oligodendroglioma Optic Nerve Diseases Optic Nerve Glioma Optic Nerve Neoplasms Paraganglioma Peripheral Nervous System Neoplasms Pheochromocytoma Pleural Neoplasms Respiratory Tract Diseases Respiratory Tract Neoplasms Sarcoma Thoracic Neoplasms Thyroid Cancer, Papillary Thyroid Carcinoma, Anaplastic Thyroid Diseases Thyroid Neoplasms

Age range

Up to 65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Ottawa Regional Cancer Centre at Ottawa Hospital - General Campus

Ottawa, Ontario, K1H 1C4, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cisplatin

Drug

Doxorubicin hydrochloride

Drug

tamoxifen citrate

Drug

conventional surgery

Procedure

radiation therapy

Radiation

Sponsors and collaborators

Lead sponsor

Ottawa Regional Cancer Centre

Other

Registry information

Official study title

Cisplatin, Doxorubicin and Tamoxifen in the Treatment of Incurable Soft Tissue and Endocrine Malignancies

Important dates

Study start
1994
Study completion
2005
First posted
Jan 27, 2003
Registry last updated
Jul 10, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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