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| Descriptive Information Fields | |||||
| Brief Title † | Combination Chemotherapy and Tamoxifen in Treating Patients With Solid Tumors | ||||
| Official Title † | 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. |
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| Detailed Description | 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. |
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| Study Phase | Phase II | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Open Label | ||||
| Primary Outcome Measure † | |||||
| Secondary Outcome Measure † | |||||
| Condition † | Adrenocortical Carcinoma Brain and Central Nervous System Tumors Head and Neck Cancer Liver Cancer Malignant Mesothelioma Pheochromocytoma Sarcoma |
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| Intervention † | Drug: cisplatin Drug: doxorubicin hydrochloride Drug: tamoxifen citrate Procedure: conventional surgery Procedure: radiation therapy |
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| MEDLINE PMIDs | |||||
| Links | Clinical trial summary from the National Cancer Institute's PDQ® database ![]() |
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| Recruitment Information Fields | |||||
| Recruitment Status † | Completed | ||||
| Enrollment † | 30 | ||||
| Start Date † | May 1994 | ||||
| Completion Date | |||||
| Eligibility Criteria † | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age:
Performance status:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY: Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
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| Gender | Both | ||||
| Ages | up to 65 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | Canada | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00002608 | ||||
| Organization ID | CDR0000063892 | ||||
| Secondary IDs †† | CAN-OTT-9401, NCI-V94-0566 | ||||
| Study Sponsor † | Ottawa Hospital Regional Cancer Centre - General Campus | ||||
| Collaborators †† | |||||
| Investigators † |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | May 2005 | ||||
| First Received Date † | November 1, 1999 | ||||
| Last Updated Date | July 23, 2008 | ||||