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Spots Global Cancer Trial Database for Combination Chemotherapy and Tamoxifen in Treating Patients With Solid Tumors

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Trial Identification

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

Study ID: NCT00002608

Study Description

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.

Keywords

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
childhood oligodendroglioma
adult anaplastic astrocytoma
adult myxopapillary ependymoma
adult anaplastic ependymoma
adult anaplastic oligodendroglioma
adult mixed glioma
adult pilocytic astrocytoma
adult subependymoma
recurrent childhood brain stem glioma
recurrent childhood cerebellar astrocytoma
recurrent childhood cerebral astrocytoma
recurrent childhood medulloblastoma
recurrent childhood visual pathway and hypothalamic glioma
recurrent childhood ependymoma
stage IV adult soft tissue sarcoma
adult oligodendroglioma
adult giant cell glioblastoma
adult gliosarcoma
adult diffuse astrocytoma

Eligibility

Minimum Age:

Eligible Ages: CHILD, ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Ottawa Regional Cancer Centre at Ottawa Hospital - General Campus, Ottawa, Ontario, Canada

Contact Details

Name: Stan Z. Gertler, MD, FRCPC

Affiliation: Ottawa Regional Cancer Centre

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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