Ignite Creation Date:
2024-05-05 @ 11:42 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00119314
Status:
WITHDRAWN
Last Update Posted:
2015-05-27
First Post:
2005-07-12
Brief Title:
Gemcitabine Docetaxel and Capecitabine in Treating Patients With Cancer of Unknown Primary Origin
Sponsor:
University of Medicine and Dentistry of New Jersey
Organization:
Rutgers The State University of New Jersey
Study Overview
Official Title:
Carcinoma Unknown Primary Treatment With Gemcitabine Docetaxel and Capecitabine GTX an Evaluation and Treatment Study of The Cancer Institute of New Jersey Oncology Group
Status:
WITHDRAWN
Status Verified Date:
2011-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
slow accrual
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 gemcitabine docetaxel and capecitabine work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Giving more than one drug combination chemotherapy may kill more tumor cells
PURPOSE This phase II trial is studying how well giving gemcitabine together with docetaxel and capecitabine works in treating patients with cancer of unknown primary origin
PURPOSE This phase II trial is studying how well giving gemcitabine together with docetaxel and capecitabine works in treating patients with cancer of unknown primary origin
Detailed Description:
OBJECTIVES
Primary
Determine the feasibility of positron emission tomography PET and pathology assessment in identifying the primary tumor site in patients with carcinoma of unknown primary
Determine the efficacy and safety of gemcitabine docetaxel and capecitabine in patients with carcinoma of unknown primary
Secondary
Determine the frequency with which PET scan and pathology assessment can define the organ of origin in these patients
OUTLINE This is a 2-part multicenter study
Part 1 Patients undergo a comprehensive standard evaluation including pathologic assessment and positron emission tomography scan to attempt to identify the primary tumor site If the primary tumor site is identified the patient proceeds to appropriate treatment for that tumor off study If the primary tumor site remains unknown the patient proceeds to chemotherapy in part 2 of the study
Part 2 Patients receive gemcitabine IV and docetaxel IV over 30 minutes on days 4 and 11 Patients also receive oral capecitabine twice daily on days 1-14 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed for 4 weeks and then every 6 months for 2 years
PROJECTED ACCRUAL Approximately 44 patients 10-29 for part 2 will be accrued for this study
Primary
Determine the feasibility of positron emission tomography PET and pathology assessment in identifying the primary tumor site in patients with carcinoma of unknown primary
Determine the efficacy and safety of gemcitabine docetaxel and capecitabine in patients with carcinoma of unknown primary
Secondary
Determine the frequency with which PET scan and pathology assessment can define the organ of origin in these patients
OUTLINE This is a 2-part multicenter study
Part 1 Patients undergo a comprehensive standard evaluation including pathologic assessment and positron emission tomography scan to attempt to identify the primary tumor site If the primary tumor site is identified the patient proceeds to appropriate treatment for that tumor off study If the primary tumor site remains unknown the patient proceeds to chemotherapy in part 2 of the study
Part 2 Patients receive gemcitabine IV and docetaxel IV over 30 minutes on days 4 and 11 Patients also receive oral capecitabine twice daily on days 1-14 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed for 4 weeks and then every 6 months for 2 years
PROJECTED ACCRUAL Approximately 44 patients 10-29 for part 2 will be accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CINJ-5073 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA072720 |
| P30CA072720 | NIH | None | None |
| CINJ-000404 | None | None | None |
| CINJ-4735 | None | None | None |
| CINJ-NJ2203 | None | None | None |