Gemcitabine in Treating Patients With Recurrent or Persistent Endometrial Cancer

NCT00820898 | Completed Phase 2 Results

• 4 other identifiers: GOG-0129QNCI-2009-01175CDR0000631591U10CA027469
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 20

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Arm I

EXPERIMENTAL

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

Interventions

Gemcitabine Hydrochloride DRUG

Given IV

Also known as: dFdCyd, Difluorodeoxycytidine Hydrochloride, Gemzar, LY-188011

Arm I

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Gynecologic Oncology Group: lead
• National Cancer Institute (NCI): collaborator

Study Sites (20)

Hartford Hospital

Hartford, Connecticut, 06102, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, 60637, United States

Location

Decatur Memorial Hospital

Decatur, Illinois, 62526, United States

Location

Memorial Medical Center

Springfield, Illinois, 62781-0001, United States

Location

Saint Vincent Hospital and Health Services

Indianapolis, Indiana, 46260, United States

Location

University of Iowa/Holden Comprehensive Cancer Center

Iowa City, Iowa, 52242, United States

Location

Maine Medical Center-Bramhall Campus

Portland, Maine, 04102, United States

Location

Cooper Hospital University Medical Center

Camden, New Jersey, 08103, United States

Location

Carolinas Medical Center

Charlotte, North Carolina, 28203, United States

Location

MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

Location

Riverside Methodist Hospital

Columbus, Ohio, 43214, United States

Location

Lake University Ireland Cancer Center

Mentor, Ohio, 44060, United States

Location

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

Tulsa Cancer Institute

Tulsa, Oklahoma, 74146, United States

Location

Abington Memorial Hospital

Abington, Pennsylvania, 19001, United States

Location

Gynecologic Oncology Group

Philadelphia, Pennsylvania, 19103, United States

Location

Women and Infants Hospital

Providence, Rhode Island, 02905, United States

Location

Zale Lipshy University Hospital

Dallas, Texas, 75235, United States

Location

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Interventions

Gemcitabine

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Angela Kuras on behalf of James Kauderer
• Organization: NRG Oncology

kurasa@nrgoncology.org

716-845-5702

Study Officials

• David Tait

  Gynecologic Oncology Group

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2009
• First Posted: January 12, 2009
• Study Start: February 1, 2009
• Primary Completion: January 1, 2011
• Last Updated: December 29, 2017
• Results First Posted: December 5, 2017

Record last verified: 2015-05

Locations

US (20)