Carcinoma Unknown Primary: Treatment With Gemcitabine, Docetaxel and Capecitabine (GTX) an Evaluation and Treatment Study of The Cancer Institute of New Jersey Oncology Group
- Determine the feasibility of positron emission tomography (PET) and pathology
assessment in identifying the primary tumor site in patients with carcinoma of unknown
- Determine the efficacy and safety of gemcitabine, docetaxel, and capecitabine in
patients with carcinoma of unknown primary.
- 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
Masking: Open Label, Primary Purpose: Treatment
Elizabeth A. Poplin, MD
Cancer Institute of New Jersey
United States: Federal Government
|Overlook Hospital||Summit, New Jersey 07902-0220|
|Carol G. Simon Cancer Center at Morristown Memorial Hospital||Morristown, New Jersey 07962|
|Cancer Institute of New Jersey at Hamilton||Hamilton, New Jersey 08690|
|Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School||New Brunswick, New Jersey 08903|
|Cancer Center at the Mountainside Hospital||Montclair, New Jersey 07042|
|Hematology and Oncology Group||Somerset, New Jersey 08873|