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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 Radiation: radiation therapy |
Phase II |
| 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 | |
| Study Chair: | Stan Z. Gertler, MD, FRCPC | Ottawa Hospital Regional Cancer Centre - General Campus |
More Information
| Study ID Numbers: | CDR0000063892, CAN-OTT-9401, NCI-V94-0566 |
| Study First Received: | November 1, 1999 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00002608 History of Changes |
| Health Authority: | United States: Federal Government |
|
childhood brain tumor childhood infratentorial ependymoma childhood supratentorial ependymoma recurrent adult soft tissue sarcoma recurrent childhood brain tumor childhood liver cancer stage IV childhood liver cancer recurrent childhood liver cancer advanced malignant mesothelioma recurrent malignant mesothelioma localized unresectable adult primary liver cancer advanced adult primary liver cancer recurrent adult primary liver cancer recurrent adult brain tumor stage IV adrenocortical carcinoma |
recurrent adrenocortical carcinoma stage IV papillary thyroid cancer stage IV follicular thyroid cancer thyroid gland medullary carcinoma anaplastic thyroid cancer recurrent thyroid cancer adult brain stem glioma adult medulloblastoma adult glioblastoma metastatic pheochromocytoma recurrent pheochromocytoma childhood soft tissue sarcoma metastatic childhood soft tissue sarcoma recurrent childhood soft tissue sarcoma childhood high-grade cerebral astrocytoma |
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Glioblastoma Liver Diseases Hormone Antagonists Thyroid Cancer, Papillary Thyroid Cancer, Medullary Hormones, Hormone Substitutes, and Hormone Antagonists Adrenal Gland Diseases Bone Density Conservation Agents Central Nervous System Neoplasms Hormones Estrogen Receptor Modulators Neoplasms, Connective and Soft Tissue Thyroid Cancer, Follicular Neuroepithelioma Glioma |
Adrenal Cortex Neoplasms Nervous System Neoplasms Endocrine Gland Neoplasms Digestive System Neoplasms Antineoplastic Agents, Hormonal Astrocytoma Citric Acid Endocrine System Diseases Tamoxifen Doxorubicin Carcinoma Brain Neoplasms Neuroectodermal Tumors Malignant Mesenchymal Tumor Brain Stem Glioma, Childhood |
|
Liver Diseases Antineoplastic Agents Neoplasms, Mesothelial Hormone Antagonists Physiological Effects of Drugs Neoplasms, Nerve Tissue Hormones, Hormone Substitutes, and Hormone Antagonists Adrenal Gland Diseases Bone Density Conservation Agents Central Nervous System Neoplasms Selective Estrogen Receptor Modulators Antibiotics, Antineoplastic Pheochromocytoma Liver Neoplasms Estrogen Receptor Modulators |
Neoplasms, Connective and Soft Tissue Paraganglioma Neoplasms by Site Cisplatin Therapeutic Uses Neoplasms, Germ Cell and Embryonal Adrenal Cortex Neoplasms Nervous System Neoplasms Endocrine Gland Neoplasms Estrogen Antagonists Neoplasms by Histologic Type Digestive System Neoplasms Antineoplastic Agents, Hormonal Adrenocortical Carcinoma Nervous System Diseases |