Gemcitabine in Treating Patients With Recurrent or Persistent Endometrial Cancer

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

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.

Study Overview

• Status: Completed
• Conditions: Recurrent Uterine Corpus Carcinoma; Endometrial Clear Cell Adenocarcinoma; Endometrial Adenocarcinoma; Endometrial Adenosquamous Carcinoma
• Intervention / Treatment: Drug: Gemcitabine Hydrochloride

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.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • Hartford, Connecticut, United States, 06102
      • Hartford Hospital
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center
    • Chicago, Illinois, United States, 60637
      • University of Chicago Comprehensive Cancer Center
    • Decatur, Illinois, United States, 62526
      • Decatur Memorial Hospital
    • Springfield, Illinois, United States, 62781-0001
      • Memorial Medical Center
  • Indiana
    • Indianapolis, Indiana, United States, 46260
      • Saint Vincent Hospital and Health Services
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa/Holden Comprehensive Cancer Center
  • Maine
    • Portland, Maine, United States, 04102
      • Maine Medical Center-Bramhall Campus
  • New Jersey
    • Camden, New Jersey, United States, 08103
      • Cooper Hospital University Medical Center
  • North Carolina
    • Charlotte, North Carolina, United States, 28203
      • Carolinas Medical Center
  • Ohio
    • Cleveland, Ohio, United States, 44109
      • MetroHealth Medical Center
    • Columbus, Ohio, United States, 43214
      • Riverside Methodist Hospital
    • Mentor, Ohio, United States, 44060
      • Lake University Ireland Cancer Center
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • University of Oklahoma Health Sciences Center
    • Tulsa, Oklahoma, United States, 74146
      • Tulsa Cancer Institute
  • Pennsylvania
    • Abington, Pennsylvania, United States, 19001
      • Abington Memorial Hospital
    • Philadelphia, Pennsylvania, United States, 19103
      • Gynecologic Oncology Group
  • Rhode Island
    • Providence, Rhode Island, United States, 02905
      • Women and Infants Hospital
  • Texas
    • Dallas, Texas, United States, 75235
      • Zale Lipshy University Hospital
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • University of Wisconsin Hospital and Clinics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Drug: Gemcitabine Hydrochloride; Given IV; Other Names: Gemzar; dFdCyd; Difluorodeoxycytidine Hydrochloride; LY-188011

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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.

Collaborators and Investigators

• Sponsor: Gynecologic Oncology Group
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: David Tait, Gynecologic Oncology Group

Study record dates

Study Major Dates

• Study Start: February 1, 2009
• Primary Completion (ACTUAL): January 1, 2011

Study Registration Dates

• First Submitted: January 9, 2009
• First Submitted That Met QC Criteria: January 9, 2009
• First Posted (ESTIMATE): January 12, 2009

Study Record Updates

• Last Update Posted (ACTUAL): December 29, 2017
• Last Update Submitted That Met QC Criteria: December 5, 2017
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Disease Attributes; Neoplasms, Complex and Mixed; Carcinoma; Recurrence; Adenocarcinoma; Adenocarcinoma, Clear Cell; Carcinoma, Adenosquamous; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Gemcitabine
• Other Study ID Numbers: GOG-0129Q (OTHER: CTEP); U10CA027469 (U.S. NIH Grant/Contract); NCI-2009-01175 (REGISTRY: CTRP (Clinical Trial Reporting Program)); CDR0000631591