Gemcitabine in Treating Patients With Recurrent or Persistent Endometrial Cancer

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. Identifier: NCT00820898
Recruitment Status : Completed
First Posted : January 12, 2009
Results First Posted : December 5, 2017
Last Update Posted : December 29, 2017
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Gynecologic Oncology Group

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 gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

Condition or disease Intervention/treatment Phase
Endometrial Adenocarcinoma Endometrial Adenosquamous Carcinoma Endometrial Clear Cell Adenocarcinoma Recurrent Uterine Corpus Carcinoma Drug: Gemcitabine Hydrochloride Phase 2

Detailed Description:


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

II. To determine the nature and degree of toxicity of this drug in these patients.

OUTLINE: This is a multicenter study.

Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 3 years.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Evaluation of Gemcitabine (Gemzar®, LY188011) in the Treatment of Recurrent or Persistent Endometrial Carcinoma
Study Start Date : February 2009
Actual Primary Completion Date : January 2011

Arm Intervention/treatment
Experimental: Arm I
Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Drug: Gemcitabine Hydrochloride
Given IV
Other Names:
  • dFdCyd
  • Difluorodeoxycytidine Hydrochloride
  • Gemzar
  • LY-188011

Primary Outcome Measures :
  1. Proportion of Patients With Objective Tumor Response Rate (Complete Response [CR] or Partial Response [PR]) Using RECIST Version 1.0 [ Time Frame: CT scan or MRI if used to follow lesion for measurable disease every other cycle until disease progression for up to 5 years. ]
    RECIST 1.0 defines complete response as the disappearance of all target lesions and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial response is defined as at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of non-target lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% decrease in the LD is required. These patients will have their response classified according to the definitions stated above. Complete and partial responses are included in the objective tumor response rate.

  2. Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 [ Time Frame: Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up ]

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

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

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 identifier (NCT number): NCT00820898

United States, Connecticut
Hartford Hospital
Hartford, Connecticut, United States, 06102
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States, 60637
Decatur Memorial Hospital
Decatur, Illinois, United States, 62526
Memorial Medical Center
Springfield, Illinois, United States, 62781-0001
United States, Indiana
Saint Vincent Hospital and Health Services
Indianapolis, Indiana, United States, 46260
United States, Iowa
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, United States, 52242
United States, Maine
Maine Medical Center-Bramhall Campus
Portland, Maine, United States, 04102
United States, New Jersey
Cooper Hospital University Medical Center
Camden, New Jersey, United States, 08103
United States, North Carolina
Carolinas Medical Center
Charlotte, North Carolina, United States, 28203
United States, Ohio
MetroHealth Medical Center
Cleveland, Ohio, United States, 44109
Riverside Methodist Hospital
Columbus, Ohio, United States, 43214
Lake University Ireland Cancer Center
Mentor, Ohio, United States, 44060
United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Tulsa Cancer Institute
Tulsa, Oklahoma, United States, 74146
United States, Pennsylvania
Abington Memorial Hospital
Abington, Pennsylvania, United States, 19001
Gynecologic Oncology Group
Philadelphia, Pennsylvania, United States, 19103
United States, Rhode Island
Women and Infants Hospital
Providence, Rhode Island, United States, 02905
United States, Texas
Zale Lipshy University Hospital
Dallas, Texas, United States, 75235
United States, Wisconsin
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
Gynecologic Oncology Group
National Cancer Institute (NCI)
Principal Investigator: David Tait Gynecologic Oncology Group

Responsible Party: Gynecologic Oncology Group Identifier: NCT00820898     History of Changes
Other Study ID Numbers: GOG-0129Q
NCI-2009-01175 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
GOG-0129Q ( Other Identifier: Gynecologic Oncology Group )
GOG-0129Q ( Other Identifier: CTEP )
U10CA027469 ( U.S. NIH Grant/Contract )
First Posted: January 12, 2009    Key Record Dates
Results First Posted: December 5, 2017
Last Update Posted: December 29, 2017
Last Verified: May 2015

Additional relevant MeSH terms:
Uterine Neoplasms
Adenocarcinoma, Clear Cell
Carcinoma, Adenosquamous
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Diseases
Genital Diseases, Female
Neoplasms, Complex and Mixed
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs