Gemcitabine in Treating Patients With Recurrent or Persistent Endometrial Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Endometrial Adenocarcinoma, Endometrial Adenosquamous Carcinoma, Endometrial Clear Cell Adenocarcinoma, Recurrent Uterine Corpus Carcinoma

Intervention / Treatment
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* Drug: Gemcitabine Hydrochloride


Participation Criteria
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Eligibility Criteria
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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 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) 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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I<br>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. | Drug: Gemcitabine Hydrochloride<br>* Given IV<br>* Other names: LY-188011;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Patients With Objective Tumor Response Rate (Complete Response [CR] or Partial Response [PR]) Using RECIST Version 1.0 | RECIST 1.0 defines complete response as the disappearance of all target lesions and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial response is defined as at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of non-target lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% decrease in the LD is required. These patients will have their response classified according to the definitions stated above. Complete and partial responses are included in the objective tumor response rate. | CT scan or MRI if used to follow lesion for measurable disease every other cycle until disease progression for up to 5 years. | 
| Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 |  | Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up |