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| Sponsors and Collaborators: |
Gynecologic Oncology Group National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00005643 |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of liposomal doxorubicin in treating patients who have advanced or recurrent sarcoma of the uterus.
| Condition | Intervention | Phase |
|---|---|---|
|
Endometrial Cancer Sarcoma |
Drug: pegylated liposomal doxorubicin hydrochloride |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | Evaluation of Doxil in the Treatment of Recurrent or Advanced Leiomyosarcoma of the Uterus |
| Study Start Date: | May 2000 |
OBJECTIVES: I. Estimate the antitumor activity of doxorubicin HCl liposome in patients with recurrent or advanced uterine sarcoma. II. Determine the nature and degree of toxicity of this drug in this patient population.
OUTLINE: Patients receive doxorubicin HCl liposome IV over 1 hour. Treatment continues every 4 weeks in the absence of unacceptable toxicity or disease progression. Patients are followed every 3 months for 2 years and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 20-30 patients will be accrued for this study within 1-1.5 years.
Eligibility| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histologically confirmed advanced, persistent or recurrent uterine sarcoma with documented disease progression after appropriate local therapy Leiomyosarcoma Malignant mixed mullerian tumor (mixed mesodermal tumor, mixed heterologous mesenchymal sarcoma) Mixed malignant Muellerian tumor (carcinosarcoma, homologous mesenchymal sarcoma) Endometrial stromal sarcoma Other uterine sarcomas Considered incurable Bidimensionally measurable disease consisting of abdominal, pelvic, chest, or other masses by palpation, x-ray, computed tomography, or ultrasound
PATIENT CHARACTERISTICS: Age: Over 21 Performance status: GOG 0-2 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT no greater than 3 times ULN Alkaline phosphatase no greater than 3 times ULN Renal: Creatinine no greater than 1.5 mg/dL Cardiovascular: LVEF normal by MUGA scan Other: No clinically significant infection No other malignancy within the past 5 years except nonmelanoma skin cancer
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior therapy with cytotoxic drugs No prior doxorubicin HCl liposome No prior doxorubicin greater than 360 mg/m2 No other concurrent antineoplastic agents Endocrine therapy: Not specified Radiotherapy: Recovered from prior radiotherapy No prior radiotherapy for any other malignancy Surgery: Recovered from prior surgery Other: No other concurrent investigational agents
Contacts and Locations
Show 49 Study Locations| Study Chair: | Gregory P. Sutton, MD | Indiana University Melvin and Bren Simon Cancer Center |
More Information
| Study ID Numbers: | CDR0000067809, GOG-0087J |
| Study First Received: | May 2, 2000 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00005643 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage IV uterine sarcoma recurrent uterine sarcoma uterine carcinosarcoma uterine leiomyosarcoma endometrial stromal sarcoma |
|
Sarcoma, Endometrial Stromal Leiomyosarcoma Genital Neoplasms, Female Uterine Diseases Endometrial Cancer Urogenital Neoplasms Doxorubicin Recurrence Genital Diseases, Female Anti-Bacterial Agents |
Neoplasms, Connective and Soft Tissue Soft Tissue Sarcomas Endometrial Neoplasms Malignant Mesenchymal Tumor Uterine Sarcoma Sarcoma Uterine Neoplasms Endometrial Stromal Sarcoma Carcinosarcoma |
|
Neoplasms by Histologic Type Antineoplastic Agents Genital Neoplasms, Female Uterine Diseases Urogenital Neoplasms Antibiotics, Antineoplastic Pharmacologic Actions Doxorubicin |
Genital Diseases, Female Neoplasms, Connective and Soft Tissue Endometrial Neoplasms Neoplasms Neoplasms by Site Therapeutic Uses Sarcoma Uterine Neoplasms |
