Gemcitabine in Treating Patients With Recurrent or Persistent Endometrial Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00820898
First received: January 9, 2009
Last updated: July 18, 2012
Last verified: July 2009
  Purpose

RATIONALE: 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.

PURPOSE: 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.


Condition Intervention Phase
Endometrial Cancer
Drug: gemcitabine hydrochloride
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Evaluation of Gemcitabine (Gemzar®, LY188011) in the Treatment of Recurrent or Persistent Endometrial Carcinoma

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Adverse events as assessed by NCI CTCAE v3.0 [ Designated as safety issue: Yes ]
  • Response [ Designated as safety issue: No ]
  • Progression-free survival [ Designated as safety issue: No ]
  • Recurrence-free survival [ Designated as safety issue: No ]

Estimated Enrollment: 51
Study Start Date: February 2009
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

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

  Eligibility

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

DISEASE CHARACTERISTICS:

  • 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)

PATIENT CHARACTERISTICS:

  • 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

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • 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
  • No prior cancer treatment that contraindicates study 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: NCT00820898

  Show 41 Study Locations
Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
Principal Investigator: David L. Tait Blumenthal Cancer Center at Carolinas Medical Center
  More Information

Additional Information:
Publications:
Responsible Party: Philip J. DiSaia, Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT00820898     History of Changes
Other Study ID Numbers: CDR0000631591, GOG-0129Q
Study First Received: January 9, 2009
Last Updated: July 18, 2012
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
endometrial adenocarcinoma
endometrial clear cell carcinoma
endometrial adenosquamous cell carcinoma
recurrent endometrial carcinoma

Additional relevant MeSH terms:
Gemcitabine
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

ClinicalTrials.gov processed this record on September 22, 2014