Gemcitabine in Treating Patients With Recurrent or Persistent Endometrial Cancer

Phase 2

Completed

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

Interventions: Drug: Gemcitabine Hydrochloride

Registration Number: NCT00820898

Lead Sponsor: Gynecologic Oncology Group

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 24

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

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm I	Gemcitabine Hydrochloride	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.

Primary Outcome Measures

Name	Time	Method
Proportion of Patients With Objective Tumor Response Rate (Complete Response [CR] or Partial Response [PR]) Using RECIST Version 1.0	CT scan or MRI if used to follow lesion for measurable disease every other cycle until disease progression for up to 5 years.	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.
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

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (20): Hartford Hospital
🇺🇸
Hartford, Connecticut, United States
Riverside Methodist Hospital
🇺🇸
Columbus, Ohio, United States
Gynecologic Oncology Group
🇺🇸
Philadelphia, Pennsylvania, United States
Decatur Memorial Hospital
🇺🇸
Decatur, Illinois, United States
Tulsa Cancer Institute
🇺🇸
Tulsa, Oklahoma, United States
MetroHealth Medical Center
🇺🇸
Cleveland, Ohio, United States
Saint Vincent Hospital and Health Services
🇺🇸
Indianapolis, Indiana, United States
Carolinas Medical Center
🇺🇸
Charlotte, North Carolina, United States
Memorial Medical Center
🇺🇸
Springfield, Illinois, United States
Maine Medical Center-Bramhall Campus
🇺🇸
Portland, Maine, United States
University of Iowa/Holden Comprehensive Cancer Center
🇺🇸
Iowa City, Iowa, United States
Lake University Ireland Cancer Center
🇺🇸
Mentor, Ohio, United States
University of Oklahoma Health Sciences Center
🇺🇸
Oklahoma City, Oklahoma, United States
Abington Memorial Hospital
🇺🇸
Abington, Pennsylvania, United States
Zale Lipshy University Hospital
🇺🇸
Dallas, Texas, United States
Women and Infants Hospital
🇺🇸
Providence, Rhode Island, United States
University of Wisconsin Hospital and Clinics
🇺🇸
Madison, Wisconsin, United States
Rush University Medical Center
🇺🇸
Chicago, Illinois, United States
University of Chicago Comprehensive Cancer Center
🇺🇸
Chicago, Illinois, United States
Cooper Hospital University Medical Center
🇺🇸
Camden, New Jersey, United States