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

This study has been terminated.
(slow accrual)
Sponsor:
Collaborator:
Information provided by:
Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier:
NCT00119314
First received: July 12, 2005
Last updated: April 14, 2011
Last verified: April 2011
  Purpose

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 Intervention Phase
Carcinoma of Unknown Primary
Drug: capecitabine
Drug: docetaxel
Drug: gemcitabine hydrochloride
Procedure: positron emission tomography
Phase 2

Study Type: Interventional
Study Design: Masking: 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

Resource links provided by NLM:


Further study details as provided by Rutgers, The State University of New Jersey:

Enrollment: 0
Study Start Date: July 2004
Study Completion Date: July 2005
Primary Completion Date: July 2005 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00119314

Locations
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
Investigators
Principal Investigator: Elizabeth A. Poplin, MD Rutgers Cancer Institute of New Jersey
  More Information

No publications provided

Responsible Party: Elizabeth Poplin, MD, UMDNJ/CINJ
ClinicalTrials.gov Identifier: NCT00119314     History of Changes
Other Study ID Numbers: CDR0000433512, P30CA072720, CINJ-000404, CINJ-4735, CINJ-NJ2203, CINJ-5073
Study First Received: July 12, 2005
Last Updated: April 14, 2011
Health Authority: United States: Federal Government

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:
Carcinoma
Neoplasms, Unknown Primary
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes
Gemcitabine
Capecitabine
Fluorouracil
Docetaxel
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators

ClinicalTrials.gov processed this record on August 20, 2014