Gemcitabine in Treating Patients With Recurrent or Persistent Endometrial Cancer

Endometrial Adenocarcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00820898
• Other study ID #: GOG-0129Q
• Secondary ID: NCI-2009-01175GO
• Status: Completed
• Phase: Phase 2
• First received: January 9, 2009
• Last updated: December 5, 2017
• Start date: February 2009

Study information

• Verified date: May 2015
• Source: Gynecologic Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 24
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Carcinoma
• Carcinoma, Adenosquamous
• Endometrial Adenocarcinoma
• Endometrial Adenosquamous Carcinoma
• Endometrial Clear Cell Adenocarcinoma
• Recurrent Uterine Corpus Carcinoma
• Uterine Neoplasms

Intervention

Drug:
• Gemcitabine Hydrochloride
Given IV

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Gynecologic Oncology Group	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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