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Status:

COMPLETED

Gemcitabine in Treating Patients With Recurrent or Persistent Endometrial Cancer

Lead Sponsor:

Gynecologic Oncology Group

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Endometrial Adenocarcinoma

Endometrial Adenosquamous Carcinoma

Eligibility:

FEMALE

18+ years

Phase:

PHASE2

Brief Summary

This phase II trial is studying the side effects of gemcitabine and to see how well it works in treating patients with recurrent or persistent endometrial cancer. Drugs used in chemotherapy, such as g...

Detailed Description

PRIMARY OBJECTIVES: I. To estimate the antitumor activity of gemcitabine hydrochloride in patients with persistent or recurrent endometrial adenocarcinoma who have failed higher priority treatment pr...

Eligibility Criteria

Inclusion

  • Inclusion Criteria:
  • Histologically confirmed endometrial adenocarcinoma
  • Recurrent or persistent disease
  • Refractory to curative therapy or established treatments
  • The following epithelial cell types are eligible:
  • Endometrioid adenocarcinoma
  • Serous adenocarcinoma
  • Undifferentiated carcinoma
  • Clear cell adenocarcinoma
  • Mixed epithelial carcinoma
  • Adenocarcinoma not otherwise specified
  • Mucinous adenocarcinoma
  • Squamous cell carcinoma
  • Transitional cell carcinoma
  • Mesonephric carcinoma
  • Measurable disease, defined as ≥1 lesion that can be accurately measured in ≥ 1 dimension as ≥ 20 mm by conventional techniques, including palpation, plain x-ray, CT scan, or MRI OR as ≥ 10 mm by spiral CT scan
  • Must have ≥ 1 target lesion
  • Tumors within a previously irradiated field are designated as target lesions provided there is documented disease progression or biopsy confirmed persistent disease ≥ 90 days after completion of radiotherapy
  • Must have received 1 prior chemotherapeutic regimen for management of endometrial cancer
  • Initial treatment may have included non-cytotoxic agents or high-dose therapy, consolidation therapy, or extended therapy administered after surgical or non-surgical assessment
  • No more than one prior cytotoxic chemotherapy regimen (either with single or combination cytotoxic drug therapy)
  • One additional non-cytotoxic regimen for management of recurrent or persistent disease is allowed
  • Not eligible for a higher priority GOG protocol, if one exists (i.e., any active Phase III GOG protocol for the same patient population)
  • GOG performance status 0-2
  • ANC ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Creatinine ≤ 1.5 times upper limit of normal (ULN)
  • Bilirubin ≤ 1.5 times ULN
  • AST and ALT ≤ 2.5 times ULN
  • Alkaline phosphatase ≤ 2.5 times ULN
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for ≥ 3 months after completion of study treatment
  • No neuropathy (sensory and motor) \> grade 1, according to NCI CTCAE v3.0
  • No active infection requiring antibiotics (except an uncomplicated urinary tract infection)
  • No other invasive malignancies within the past 5 years except non-melanoma skin cancer
  • No prior cancer treatment that contraindicates study therapy
  • Recovered from prior surgery, radiotherapy, or chemotherapy
  • At least 1 week since prior hormonal therapy for endometrial cancer
  • At least 3 weeks since prior biological therapy, immunotherapy, or other therapy for endometrial cancer
  • At least 4 weeks since prior radiotherapy
  • More than 3 years since prior radiotherapy for localized breast cancer, head and neck cancer, or skin cancer and
  • No recurrent or persistent breast cancer, head and neck cancer, or skin cancer
  • More than 3 years since prior adjuvant chemotherapy for localized breast cancer
  • No recurrent or metastatic breast cancer
  • No prior radiotherapy to any portion of the abdominal cavity or pelvis except for the treatment of endometrial cancer
  • No prior chemotherapy for any abdominal or pelvic tumor except for the treatment of endometrial cancer
  • No prior gemcitabine hydrochloride

Exclusion

    Key Trial Info

    Start Date :

    February 1 2009

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    Estimated Enrollment :

    24 Patients enrolled

    Trial Details

    Trial ID

    NCT00820898

    Start Date

    February 1 2009

    Last Update

    December 29 2017

    Active Locations (20)

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

    Page 1 of 5 (20 locations)

    1

    Hartford Hospital

    Hartford, Connecticut, United States, 06102

    2

    Rush University Medical Center

    Chicago, Illinois, United States, 60612

    3

    University of Chicago Comprehensive Cancer Center

    Chicago, Illinois, United States, 60637

    4

    Decatur Memorial Hospital

    Decatur, Illinois, United States, 62526