Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002608
Status:
COMPLETED
Last Update Posted:
2013-07-10
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy and Tamoxifen in Treating Patients With Solid Tumors
Sponsor:
Ottawa Regional Cancer Centre
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Cisplatin Doxorubicin and Tamoxifen in the Treatment of Incurable Soft Tissue and Endocrine Malignancies
Status:
COMPLETED
Status Verified Date:
2005-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 mgm2 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
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 mgm2 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
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000063892 | REGISTRY | None | None |
| NCI-V94-0566 | Registry Identifier | PDQ Physician Data Query | None |