Combination Chemotherapy and Tamoxifen in Treating Patients With Solid Tumors

This study has been completed.

Sponsor:

Information provided by:

National Cancer Institute (NCI)

ClinicalTrials.gov Identifier:

NCT00002608

First received: November 1, 1999

Last updated: February 6, 2009

Last verified: May 2005

History of Changes

Tracking Information

First Received Date ^ICMJE

November 1, 1999

Last Updated Date

February 6, 2009

Start Date ^ICMJE

May 1994

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00002608 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Combination Chemotherapy and Tamoxifen in Treating Patients With Solid Tumors

Official Title ^ICMJE

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 Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Adrenocortical Carcinoma
Brain and Central Nervous System Tumors
Head and Neck Cancer
Liver Cancer
Malignant Mesothelioma
Pheochromocytoma
Sarcoma

Intervention ^ICMJE

Drug: cisplatin
Drug: doxorubicin hydrochloride
Drug: tamoxifen citrate
Procedure: conventional surgery
Radiation: radiation therapy

Study Arm (s)

Not Provided

Publications *

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 ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Canada

Administrative Information

NCT Number ^ICMJE

NCT00002608

Other Study ID Numbers ^ICMJE

CDR0000063892, CAN-OTT-9401, NCI-V94-0566

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Ottawa Regional Cancer Centre

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:

Stan Z. Gertler, MD, FRCPC

Ottawa Regional Cancer Centre

Information Provided By

National Cancer Institute (NCI)

Verification Date

May 2005

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

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