Gemcitabine in Treating Patients With Recurrent or Persistent Endometrial Cancer

• 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 ]

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.

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.

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