Brief Title
Docetaxel in Treating Patients With Recurrent or Persistent Endometrial Carcinoma (Cancer)
Official Title
A Phase II Evaluation of Weekly Docetaxel (NSC #628503) in the Treatment of Recurrent or Persistent Endometrial Carcinoma
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop
tumor cells from dividing so they stop growing or die.
PURPOSE: This phase II trial is studying how well docetaxel works in treating patients with
recurrent or persistent endometrial carcinoma (cancer).
Detailed Description
OBJECTIVES:
- Determine the antitumor activity of docetaxel in patients with recurrent or persistent
endometrial carcinoma.
- Determine the toxicity of this drug in these patients.
OUTLINE: This is a multicenter study.
Patients receive docetaxel IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days
in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 19-51 patients will be accrued for this study within 10-18
months.
Study Phase
Phase 2
Study Type
Interventional
Condition
Endometrial Cancer
Intervention
docetaxel
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Start Date
July 2004
Primary Completion Date
December 2005
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed endometrial carcinoma
- Recurrent or persistent disease
- Refractory to curative or standard therapy
- Measurable disease
- At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques
OR ≥ 10 mm by spiral CT scan
- At least 1 target lesion
- Tumors within a previously irradiated field are not considered target
lesions
- Received 1 prior chemotherapy regimen for endometrial carcinoma, including high-dose,
consolidation, or extended therapy administered after surgical or non-surgical
assessment
- One additional non-cytotoxic regimen for recurrent or persistent disease allowed,
including monoclonal antibodies, cytokines, and small-molecule inhibitors of
signal transduction
- Ineligible for a higher priority GOG protocol
PATIENT CHARACTERISTICS:
Age
- Any age
Performance status
- GOG 0-2
Life expectancy
- Not specified
Hematopoietic
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
Hepatic
- SGOT ≤ 2.5 times upper limit of normal (ULN)
- Alkaline phosphatase ≤ 2.5 times ULN
- Bilirubin ≤ 1.5 times ULN
Renal
- Creatinine ≤ 1.5 times ULN
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No neuropathy (sensory and motor) ≥ grade 2
- No active infection requiring antibiotics
- No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy
- See Disease Characteristics
- At least 3 weeks since prior biologic or immunologic therapy for malignant tumor
- No concurrent prophylactic growth factors
- No concurrent prophylactic thrombopoietic agents
Chemotherapy
- See Disease Characteristics
- Recovered from prior chemotherapy
- No more than 1 prior cytotoxic chemotherapy regimen (single or combination cytotoxic
drugs)
Endocrine therapy
- At least 1 week since prior hormonal therapy for malignant tumor
- Concurrent hormone replacement therapy allowed
Radiotherapy
- See Disease Characteristics
- Recovered from prior radiotherapy
Surgery
- Recovered from prior surgery
Other
- At least 3 weeks since other prior therapy for malignant tumor
- No prior anticancer therapy that would preclude current protocol therapy
- No concurrent amifostine or other protective reagents
Gender
Female
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
Agustin Garcia, MD, ,
Location Countries
Australia
Location Countries
Australia
Administrative Informations
NCT ID
NCT00085332
Organization ID
GOG-0129N
Secondary IDs
CDR0000368634
Responsible Party
Sponsor
Study Sponsor
Gynecologic Oncology Group
Collaborators
National Cancer Institute (NCI)
Study Sponsor
Agustin Garcia, MD, Study Chair, Premiere Oncology
Verification Date
January 2014