Gemcitabine in Treating Patients With Recurrent or Persistent Endometrial Cancer

NCT ID: NCT00820898

Last Updated: 2017-12-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-02-28

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.

Conditions

Endometrial Adenocarcinoma; Endometrial Adenosquamous Carcinoma; Endometrial Clear Cell Adenocarcinoma; Recurrent Uterine Corpus Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm I

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.

Group Type: EXPERIMENTAL

Gemcitabine Hydrochloride

Intervention Type: DRUG

Given IV

Interventions

Gemcitabine Hydrochloride

Given IV

Intervention Type: DRUG

Other Intervention Names

dFdCyd; Difluorodeoxycytidine Hydrochloride; Gemzar; LY-188011

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Gynecologic Oncology Group

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Tait

Role: PRINCIPAL_INVESTIGATOR

Gynecologic Oncology Group

Locations

Hartford Hospital

Hartford, Connecticut, United States

Rush University Medical Center

Chicago, Illinois, United States

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, United States

Decatur Memorial Hospital

Decatur, Illinois, United States

Memorial Medical Center

Springfield, Illinois, United States

Saint Vincent Hospital and Health Services

Indianapolis, Indiana, United States

University of Iowa/Holden Comprehensive Cancer Center

Iowa City, Iowa, United States

Maine Medical Center-Bramhall Campus

Portland, Maine, United States

Cooper Hospital University Medical Center

Camden, New Jersey, United States

Carolinas Medical Center

Charlotte, North Carolina, United States

MetroHealth Medical Center

Cleveland, Ohio, United States

Riverside Methodist Hospital

Columbus, Ohio, United States

Lake University Ireland Cancer Center

Mentor, Ohio, United States

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Tulsa Cancer Institute

Tulsa, Oklahoma, United States

Abington Memorial Hospital

Abington, Pennsylvania, United States

Gynecologic Oncology Group

Philadelphia, Pennsylvania, United States

Women and Infants Hospital

Providence, Rhode Island, United States

Zale Lipshy University Hospital

Dallas, Texas, United States

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, United States

Countries

United States

Other Identifiers

NCI-2009-01175

Identifier Type: REGISTRY

Identifier Source: secondary_id

GOG-0129Q

Identifier Type: -

Identifier Source: secondary_id

CDR0000631591

Identifier Type: -

Identifier Source: secondary_id

GOG-0129Q

Identifier Type: OTHER

Identifier Source: secondary_id

GOG-0129Q

Identifier Type: OTHER

Identifier Source: secondary_id

U10CA027469

Identifier Type: NIH

Identifier Source: secondary_id

View Link

GOG-0129Q

Identifier Type: -

Identifier Source: org_study_id