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Gemcitabine, Docetaxel, and Capecitabine in Treating Patients With Cancer of Unknown Primary Origin

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00119314
Recruitment Status : Withdrawn (slow accrual)
First Posted : July 13, 2005
Last Update Posted : May 27, 2015
National Cancer Institute (NCI)
Information provided by:
Rutgers, The State University of New Jersey

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.

Condition or disease Intervention/treatment Phase
Carcinoma of Unknown Primary Drug: capecitabine Drug: docetaxel Drug: gemcitabine hydrochloride Procedure: positron emission tomography Phase 2

Detailed Description:



  • 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.


  • 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : July 2004
Actual Primary Completion Date : July 2005
Actual Study Completion Date : July 2005

Resource links provided by the National Library of Medicine

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • More than 3 months


  • Hemoglobin ≥ 9.0 g/dL
  • Granulocyte count > 1,500/mm^3
  • Platelet count > 100,000/mm^3


  • 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


  • Creatinine ≤ 1.5 mg/dL


  • Able to take oral medication
  • Intestinal absorption intact

    • No uncontrolled diarrhea and/or daily emesis


  • 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


Biologic therapy

  • Not specified


  • No prior chemotherapy for this malignancy

Endocrine therapy

  • Not specified


  • 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


  • See Disease Characteristics


  • No concurrent antiviral therapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00119314

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United States, New Jersey
Cancer Institute of New Jersey at Hamilton
Hamilton, New Jersey, United States, 08690
Cancer Center at the Mountainside Hospital
Montclair, New Jersey, United States, 07042
Carol G. Simon Cancer Center at Morristown Memorial Hospital
Morristown, New Jersey, United States, 07962
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08903
Hematology and Oncology Group
Somerset, New Jersey, United States, 08873
Overlook Hospital
Summit, New Jersey, United States, 07902-0220
Sponsors and Collaborators
University of Medicine and Dentistry of New Jersey
National Cancer Institute (NCI)
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Principal Investigator: Elizabeth A. Poplin, MD Rutgers Cancer Institute of New Jersey
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Responsible Party: Elizabeth Poplin, MD, UMDNJ/CINJ
ClinicalTrials.gov Identifier: NCT00119314    
Other Study ID Numbers: CDR0000433512
P30CA072720 ( U.S. NIH Grant/Contract )
First Posted: July 13, 2005    Key Record Dates
Last Update Posted: May 27, 2015
Last Verified: April 2011
Keywords provided by Rutgers, The State University of New Jersey:
newly diagnosed carcinoma of unknown primary
recurrent carcinoma of unknown primary
Additional relevant MeSH terms:
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Neoplasms, Unknown Primary
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators