Completed

A Phase II Evaluation of Weekly Docetaxel (NSC #628503) in the Treatment of Recurrent or Persistent Endometrial Carcinoma

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What is being tested

Data Collection

Who is being recruted

Urogenital Diseases+12

+ Genital Diseases

+ Carcinoma

See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: July 2004
See protocol details

Summary

Principal SponsorGynecologic Oncology Group
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: July 1, 2004

Actual date on which the first participant was enrolled.

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.

Official TitleA Phase II Evaluation of Weekly Docetaxel (NSC #628503) in the Treatment of Recurrent or Persistent Endometrial Carcinoma 
NCT00085332
Principal SponsorGynecologic Oncology Group
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesGenital DiseasesCarcinomaFemale Urogenital Diseases and Pregnancy ComplicationsGenital Diseases, FemaleGenital Neoplasms, FemaleNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Glandular and EpithelialUrogenital NeoplasmsUterine DiseasesUterine NeoplasmsEndometrial NeoplasmsFemale Urogenital Diseases

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

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 75 locations

Suspended

Comprehensive Cancer Center at University of Alabama at Birmingham

Birmingham, United StatesSee the location
Suspended

CCOP - Western Regional, Arizona

Phoenix, United States
Suspended

Jonsson Comprehensive Cancer Center at UCLA

Los Angeles, United States
Suspended

Women's Cancer Center - Los Gatos

Los Gatos, United States
Completed75 Study Centers