- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00119314
Gemcitabine, Docetaxel, and Capecitabine in Treating Patients With Cancer of Unknown Primary Origin
Carcinoma Unknown Primary: Treatment With Gemcitabine, Docetaxel and Capecitabine (GTX) an Evaluation and Treatment Study of The Cancer Institute of New Jersey Oncology Group
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Phase
- Phase 2
Contacts and Locations
Study Locations
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-
New Jersey
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Hamilton, New Jersey, United States, 08690
- Cancer Institute of New Jersey at Hamilton
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Montclair, New Jersey, United States, 07042
- Cancer Center at the Mountainside Hospital
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Morristown, New Jersey, United States, 07962
- Carol G. Simon Cancer Center at Morristown Memorial Hospital
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New Brunswick, New Jersey, United States, 08903
- Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
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Somerset, New Jersey, United States, 08873
- Hematology and Oncology Group
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Summit, New Jersey, United States, 07902-0220
- Overlook Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed malignancy for which no primary origin has been identified despite routine workup, including the following:
- History and physical examination
- Chemistry profile and other blood work, including tumor markers with follow up on any positive findings
- CT scan or MRI of the chest, abdomen, and pelvis
- Mammography (for female patients)
- Prostate examination (for male patients)
- Stool guaiac
Measurable disease
- Previously irradiated lesions are not considered measurable disease unless there is documented clear tumor progression in these lesions after completion of radiotherapy
The following tumor types or presentations are excluded:
- Resectable disease
Tumors consistent with germ cell primary, as indicated by any of the following:
- Midline tumor
- Elevated beta human chorionic gonadotropin
- Elevated alpha-fetoprotein
- i12p chromosomal alteration
- Prostate primary with elevated prostate-specific antigen
- Females with axillary nodes as the primary disease site
- Tumors limited to the peritoneal cavity consistent with primary peritoneal carcinoma
- Neuroendocrine tumors
- Squamous cell carcinoma involving cervical or inguinal lymph nodes
No symptomatic brain metastases
- Prior brain metastases allowed provided patient completed definitive treatment with brain irradiation with or without resection
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-2
Life expectancy
- More than 3 months
Hematopoietic
- Hemoglobin ≥ 9.0 g/dL
- Granulocyte count > 1,500/mm^3
- Platelet count > 100,000/mm^3
Hepatic
- Bilirubin normal
Meets 1 of the following criteria:
- Alkaline phosphatase (AP) normal AND AST and ALT ≤ 5 times upper limit normal (ULN)
- AP ≤ 2.5 times ULN AND AST and ALT ≤ 1.5 times ULN
- AP ≤ 5 times ULN AND AST and ALT normal
- Albumin ≥ 3.0 g/dL
Renal
- Creatinine ≤ 1.5 mg/dL
Gastrointestinal
- Able to take oral medication
Intestinal absorption intact
- No uncontrolled diarrhea and/or daily emesis
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective barrier contraception during and for 3 months after completion of study treatment
- No other malignancy within the past 5 years except curatively treated carcinoma in situ of the cervix or basal cell skin cancer
- No severe medical or psychiatric illness that would preclude study treatment
- No peripheral neuropathy > grade 1
- No history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- No prior chemotherapy for this malignancy
Endocrine therapy
- Not specified
Radiotherapy
- See Disease Characteristics
- Recovered from prior radiotherapy
- Prior palliative radiotherapy to areas of bony metastases allowed provided there is measurable disease outside the radiotherapy port
- At least 4 weeks since prior radiotherapy
- No prior radiotherapy to ≥ 25% of the bone marrow
Surgery
- See Disease Characteristics
Other
- No concurrent antiviral therapy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Masking: None (Open Label)
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Elizabeth A. Poplin, MD, Rutgers Cancer Institute of New Jersey
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms, Glandular and Epithelial
- Neoplastic Processes
- Neoplasm Metastasis
- Carcinoma
- Neoplasms, Unknown Primary
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Gemcitabine
- Docetaxel
- Capecitabine
Other Study ID Numbers
- CDR0000433512
- P30CA072720 (U.S. NIH Grant/Contract)
- CINJ-000404
- CINJ-4735
- CINJ-NJ2203
- CINJ-5073
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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