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Status:

WITHDRAWN

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

Lead Sponsor:

University of Medicine and Dentistry of New Jersey

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Carcinoma of Unknown Primary

Eligibility:

All Genders

18+ years

Phase:

PHASE2

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 ...

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. * ...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    July 1 2004

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    July 1 2005

    Estimated Enrollment :

    Patients enrolled

    Trial Details

    Trial ID

    NCT00119314

    Start Date

    July 1 2004

    End Date

    July 1 2005

    Last Update

    May 27 2015

    Active Locations (6)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 2 (6 locations)

    1

    Cancer Institute of New Jersey at Hamilton

    Hamilton, New Jersey, United States, 08690

    2

    Cancer Center at the Mountainside Hospital

    Montclair, New Jersey, United States, 07042

    3

    Carol G. Simon Cancer Center at Morristown Memorial Hospital

    Morristown, New Jersey, United States, 07962

    4

    Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School

    New Brunswick, New Jersey, United States, 08903