Combination Chemotherapy and Tamoxifen in Treating Patients With Solid Tumors

Head and Neck Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002608
• Other study ID #: CAN-OTT-9401
• Secondary ID: CDR0000063892NCI
• Status: Completed
• Phase: Phase 2
• First received: November 1, 1999
• Last updated: July 9, 2013
• Start date: May 1994
• Est. completion date: April 2005

Study information

• Verified date: May 2005
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 65 Years

Eligibility

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

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• cisplatin

• doxorubicin hydrochloride

• tamoxifen citrate

Procedure:
• conventional surgery

Radiation:
• radiation therapy

Locations

Country	Name	City	State
Canada	Ottawa Regional Cancer Centre at Ottawa Hospital - General Campus	Ottawa	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Ottawa Regional Cancer Centre

Country where clinical trial is conducted

Canada, 

References & Publications (1)

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