A Phase II Evaluation of Gemcitabine (Gemzar®, LY188011) in the Treatment of Recurrent or Persistent Endometrial Carcinoma
A Phase II Evaluation of Gemcitabine (Gemzar®, LY188011) in the Treatment of Recurrent or Persistent Endometrial Carcinoma
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.
PRIMARY OBJECTIVES:
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.
Inclusion Criteria:
Histologically confirmed endometrial adenocarcinoma
The following epithelial cell types are eligible:
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
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)
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
More than 3 years since prior adjuvant chemotherapy for localized 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