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

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