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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
N/A
Not Enrolling
Female
Endometrial Cancer

Thank you

Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Adverse events as assessed by NCI CTCAE v3.0

Safety Issue:

Yes

Principal Investigator

David L. Tait

Investigator Role:

Principal Investigator

Investigator Affiliation:

Blumenthal Cancer Center at Carolinas Medical Center

Authority:

United States: Federal Government

Study ID:

CDR0000631591

NCT ID:

NCT00820898

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

Name

Location

University of Chicago Cancer Research CenterChicago, Illinois  60637
Duke Comprehensive Cancer CenterDurham, North Carolina  27710
George Bray Cancer Center at the Hospital of Central Connecticut - New Britain CampusNew Britain, Connecticut  06050
Hinsdale Hematology Oncology AssociatesHinsdale, Illinois  60521
Bronson Methodist HospitalKalamazoo, Michigan  49007
West Michigan Cancer CenterKalamazoo, Michigan  49007-3731
Borgess Medical CenterKalamazooaa, Michigan  49001
Case Comprehensive Cancer CenterCleveland, Ohio  44106-5065
MetroHealth Cancer Care Center at MetroHealth Medical CenterCleveland, Ohio  44109
University of Wisconsin Paul P. Carbone Comprehensive Cancer CenterMadison, Wisconsin  53792-6164
CCOP - Cancer Research for the OzarksSpringfield, Missouri  65807
Rush University Medical CenterChicago, Illinois  60612-3824
Holden Comprehensive Cancer Center at University of IowaIowa City, Iowa  52242-1002
Fletcher Allen Health Care - University Health Center CampusBurlington, Vermont  05401
Blumenthal Cancer Center at Carolinas Medical CenterCharlotte, North Carolina  28232-2861
Hulston Cancer Center at Cox Medical Center SouthSpringfield, Missouri  65807
St. John's Regional Health CenterSpringfield, Missouri  65804
Lake/University Ireland Cancer CenterMentor, Ohio  44060
Women and Infants Hospital of Rhode IslandProvidence, Rhode Island  02905
St. Vincent Indianapolis HospitalIndianapolis, Indiana  46260
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - DallasDallas, Texas  75390
Riverside Methodist Hospital Cancer CareColumbus, Ohio  43214
University of Mississippi Cancer ClinicJackson, Mississippi  39216-4505
Oklahoma University Cancer InstituteOklahoma City, Oklahoma  73104
Virginia Commonwealth University Massey Cancer CenterRichmond, Virginia  23298-0037
Robert H. Lurie Comprehensive Cancer Center at Northwestern UniversityChicago, Illinois  60611
Decatur Memorial Hospital Cancer Care InstituteDecatur, Illinois  62526
Helen and Harry Gray Cancer Center at Hartford HospitalHartford, Connecticut  06102-5037
Maine Medical Center - Bramhall CampusPortland, Maine  04102
Women's Cancer Center - Lake MeadLas Vegas, Nevada  89102
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical CenterColumbus, Ohio  43210-1240
Cancer Care Associates - Saint Francis CampusTulsa, Oklahoma  74136-1929
Rosenfeld Cancer Center at Abington Memorial HospitalAbington, Pennsylvania  19001
Parkland Memorial HospitalDallas, Texas  75235
UT Southwestern University Hospital - Zale LipshyDallas, Texas  75235
Cancer Institute of New Jersey at Cooper - VoorheesVoorhees, New Jersey  08043
David L. Rike Cancer Center at Miami Valley HospitalDayton, Ohio  45409
McGlinn Family Regional Cancer Center at Reading Hospital and Medical CenterReading, Pennsylvania  19612-6052
Woman's HospitalBaton Rouge, Louisiana  70815
Regional Cancer Center at Memorial Medical CenterSpringfield, Illinois  62781-0001
St. Dominic Cancer CenterJackson, Mississippi  39216