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Mesothelioma Related Clinical Trials:
Cisplatin, Doxorubicin and Tamoxifen in the Treatment of Incurable Soft Tissue and Endocrine Malignancies
- General Info - Purpose - Eligibility - Contacts & Locations - Additional Information
Status: Completed
Sponsors and Collaborators: Ottawa Hospital Regional Cancer Centre - General Campus
Information provided by: National Cancer Institute (NCI)
Government Identifier: NCT00002608
Condition: Adrenocortical Carcinoma; Brain and Central Nervous System Tumors; Head and Neck Cancer; Liver Cancer; Malignant Mesothelioma; Pheochromocytoma; Sarcoma
Intervention: Drug: cisplatin; Drug: doxorubicin hydrochloride; Drug: tamoxifen citrate; Procedure: antiestrogen therapy; Procedure: chemotherapy; Procedure: conventional surgery; Procedure: drug modulation therapy; Procedure: radiation therapy
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.
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | Cisplatin, Doxorubicin and Tamoxifen in the Treatment of Incurable Soft Tissue and Endocrine Malignancies |
| 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: NCT00002608Locations
| 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 |
Additional Information:
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: | January 26, 2008 |
| ClinicalTrials.gov Identifier: | NCT00002608 |
| Health Authority: | United States: Federal Government |
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