A Phase II Evaluation of Gemcitabine (Gemzar®, LY188011) in the Treatment of Recurrent or Persistent Endometrial Carcinoma
Overview
- Phase
- Phase 2
- Intervention
- Gemcitabine Hydrochloride
- Conditions
- Endometrial Adenocarcinoma
- Sponsor
- Gynecologic Oncology Group
- Enrollment
- 24
- Locations
- 20
- Primary Endpoint
- Proportion of Patients With Objective Tumor Response Rate (Complete Response [CR] or Partial Response [PR]) Using RECIST Version 1.0
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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.
Investigators
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
Exclusion Criteria
- Not provided
Arms & Interventions
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.
Intervention: Gemcitabine Hydrochloride
Outcomes
Primary Outcomes
Proportion of Patients With Objective Tumor Response Rate (Complete Response [CR] or Partial Response [PR]) Using RECIST Version 1.0
Time Frame: 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
Time Frame: Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up