Combination Chemotherapy and Tamoxifen in Treating Patients With Solid Tumors

NCT ID: NCT00002608

Last Updated: 2013-07-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1994-05-31
• Study Completion Date: 2005-04-30

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.

Conditions

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

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

cisplatin

Intervention Type: DRUG

doxorubicin hydrochloride

Intervention Type: DRUG

tamoxifen citrate

Intervention Type: DRUG

conventional surgery

Intervention Type: PROCEDURE

radiation therapy

Intervention Type: RADIATION

Eligibility Criteria

Inclusion 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

• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ottawa Regional Cancer Centre

OTHER

Sponsor Role: lead

Principal Investigators

Stan Z. Gertler, MD, FRCPC

Role: STUDY_CHAIR

Ottawa Regional Cancer Centre

Locations

Ottawa Regional Cancer Centre at Ottawa Hospital - General Campus

Ottawa, Ontario, Canada

Countries

Canada

References

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.

Reference Type: RESULT

Other Identifiers

CDR0000063892

Identifier Type: REGISTRY

Identifier Source: secondary_id

NCI-V94-0566

Identifier Type: -

Identifier Source: secondary_id

CAN-OTT-9401

Identifier Type: -

Identifier Source: org_study_id