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| Sponsored by: |
Ottawa Hospital Regional Cancer Centre - General Campus |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00002608 |
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.
| Condition | Intervention | Phase |
|
Adrenocortical Carcinoma Brain and Central Nervous System Tumors Head and Neck Cancer Liver Cancer Malignant Mesothelioma Pheochromocytoma Sarcoma |
Drug: cisplatin Drug: doxorubicin hydrochloride Drug: tamoxifen citrate Procedure: conventional surgery Procedure: radiation therapy |
Phase II |
| Genetics Home Reference related topics: | Pheochromocytoma Soft Tissue Sarcoma |
| MedlinePlus related topics: | Brain Cancer Cancer Childhood Brain Tumors Head and Neck Cancer Liver Cancer Mesothelioma Pheochromocytoma Soft Tissue Sarcoma Thyroid Cancer |
| ChemIDplus related topics: | Doxorubicin Doxorubicin hydrochloride Cisplatin Tamoxifen Tamoxifen citrate Citric acid Sodium Citrate Thyroid |
| 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 |
OBJECTIVES:
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 |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Contacts and Locations| Canada, Ontario | |||||
| Ottawa Regional Cancer Centre at Ottawa Hospital - General Campus | |||||
| Ottawa, Ontario, Canada, K1H 1C4 | |||||
| Ottawa Hospital Regional Cancer Centre - General Campus |
| Study Chair: | Stan Z. Gertler, MD, FRCPC | Ottawa Hospital Regional Cancer Centre - General Campus |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
| 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: | May 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00002608 |
| Health Authority: | United States: Federal Government |
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