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A Phase II Evaluation of Gemcitabine (Gemzar®, LY188011) in the Treatment of Recurrent or Persistent Endometrial Carcinoma

Phase 2
18 Years
Not Enrolling
Endometrial Cancer

Thank you

Trial Information

A Phase II Evaluation of Gemcitabine (Gemzar®, LY188011) in the Treatment of Recurrent or Persistent Endometrial Carcinoma


- 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.

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

- 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

- No other invasive malignancies within the past 5 years except non-melanoma skin


- 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

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Adverse events as assessed by NCI CTCAE v3.0

Safety Issue:


Principal Investigator

David L. Tait

Investigator Role:

Principal Investigator

Investigator Affiliation:

Blumenthal Cancer Center at Carolinas Medical Center


United States: Federal Government

Study ID:




Start Date:

February 2009

Completion Date:

Related Keywords:

  • Endometrial Cancer
  • endometrial adenocarcinoma
  • endometrial clear cell carcinoma
  • endometrial adenosquamous cell carcinoma
  • recurrent endometrial carcinoma
  • Endometrial Neoplasms
  • Sarcoma, Endometrial Stromal
  • Adenoma



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Case Comprehensive Cancer Center Cleveland, Ohio  44106-5065
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Rush University Medical Center Chicago, Illinois  60612-3824
Holden Comprehensive Cancer Center at University of Iowa Iowa City, Iowa  52242-1002
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Hulston Cancer Center at Cox Medical Center South Springfield, Missouri  65807
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Lake/University Ireland Cancer Center Mentor, Ohio  44060
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University of Mississippi Cancer Clinic Jackson, Mississippi  39216-4505
Oklahoma University Cancer Institute Oklahoma City, Oklahoma  73104
Virginia Commonwealth University Massey Cancer Center Richmond, Virginia  23298-0037
Robert H. Lurie Comprehensive Cancer Center at Northwestern University Chicago, Illinois  60611
Decatur Memorial Hospital Cancer Care Institute Decatur, Illinois  62526
Helen and Harry Gray Cancer Center at Hartford Hospital Hartford, Connecticut  06102-5037
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McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center Reading, Pennsylvania  19612-6052
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Regional Cancer Center at Memorial Medical Center Springfield, Illinois  62781-0001
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