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| Sponsors and Collaborators: |
New York University School of Medicine National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00003334 |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining doxorubicin and paclitaxel in treating patients who have recurrent or refractory endometrial cancer, fallopian tube cancer, or sarcoma of the female reproductive tract.
| Condition | Intervention | Phase |
|---|---|---|
|
Endometrial Cancer Fallopian Tube Cancer Ovarian Cancer Sarcoma |
Drug: paclitaxel Drug: pegylated liposomal doxorubicin hydrochloride |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | Phase II Study of Doxil and Paclitaxel in Patients With Endometrial, Tubal, and Sarcomas of Gynecologic Origin |
| Study Start Date: | March 1997 |
OBJECTIVES: I. Determine the response rate and duration of response to doxorubicin HCl liposome and paclitaxel in patients with endometrial cancer, tubal cancers, and sarcomas and carcinosarcomas (mixed mesodermal tumors) of gynecologic origin. II. Define the safety profile of the combination of doxorubicin HCl liposome and paclitaxel in this patient population.
OUTLINE: Patients are stratified into two groups. Group 1 consists of patients with untreated endometrial and tubal cancers and Group 2 consists of patients with sarcomas and carcinosarcomas (mixed mesodermal tumors) of gynecologic origin subdivided into no or prior therapy. Patients receive doxorubicin HCl liposome intravenously on day 1 of each treatment course. Paclitaxel is administered intravenously weekly on days 1, 8, and 15 of each course. Courses are repeated every 21 days. Treatment continues in the absence of unacceptable toxic effects or disease progression. Patients are followed every 3 months for 2 years, then every 6 months for 3 years, then annually thereafter.
PROJECTED ACCRUAL: A total of 28-60 patients will be accrued for this study.
Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed recurrent or refractory carcinoma of the endometrium or fallopian tubes or sarcomas of gynecologic origin including mixed mesodermal sarcomas Documented recurrence or persistence of disease after appropriate surgical and/or radiation therapy Measurable or evaluable disease
PATIENT CHARACTERISTICS: Age: Not specified Performance status: Not specified Life expectancy: Not specified Hematopoietic: Platelet count at least 50,000/mm3 Granulocyte count at least 1,000/mm3 Hepatic: SGOT and SGPT no greater than 3 times upper limit of normal (ULN) Bilirubin no greater than 3 times ULN Renal: Creatinine less than 2.5 mg/dL Cardiovascular: MUGA at least lower limit of normal Normal ejection fraction and/or stable cardiac status Other: No medical or social factors that would interfere with compliance Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No serious concurrent illness requiring immediate therapy
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 6 months since prior combined modality or adjuvant chemotherapy Prior doxorubicin allowed if cumulative dose is recorded Endocrine therapy: Not specified Radiotherapy: No concurrent radiotherapy Surgery: Not specified Other: At least 30 days since prior noncytotoxic experimental antiemetic or antifungal investigational drugs
Contacts and Locations| United States, New York | |
| Albert Einstein Comprehensive Cancer Center | |
| Bronx, New York, United States, 10461 | |
| Mount Sinai Medical Center, NY | |
| New York, New York, United States, 10029 | |
| New York Medical College | |
| Valhalla, New York, United States, 10595 | |
| New York Presbyterian Hospital - Cornell Campus | |
| New York, New York, United States, 10021 | |
| NYU School of Medicine's Kaplan Comprehensive Cancer Center | |
| New York, New York, United States, 10016 | |
| Study Chair: | Franco M. Muggia, MD | New York University School of Medicine |
More Information
| Study ID Numbers: | CDR0000066300, NYU-9708, NYGOG-NY9708, NCI-G98-1427 |
| Study First Received: | November 1, 1999 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00003334 |
| Health Authority: | United States: Federal Government |
|
stage IV endometrial carcinoma recurrent endometrial carcinoma fallopian tube cancer stage IV uterine sarcoma recurrent uterine sarcoma |
uterine carcinosarcoma uterine leiomyosarcoma endometrial stromal sarcoma ovarian sarcoma ovarian carcinosarcoma |
|
Sarcoma, Endometrial Stromal Leiomyosarcoma Gonadal Disorders Malignant mesenchymal tumor Urogenital Neoplasms Ovarian Diseases Soft tissue sarcomas Genital Diseases, Female Ovarian carcinosarcoma Neoplasms, Connective and Soft Tissue Endometrial Neoplasms Uterine Neoplasms Endometrial cancer Endocrine Gland Neoplasms Ovarian cancer |
Ovarian Neoplasms Endometrial stromal sarcoma Genital Neoplasms, Female Endocrine System Diseases Uterine Diseases Doxorubicin Recurrence Fallopian Tube Neoplasms Carcinoma Fallopian Tube Diseases Paclitaxel Sarcoma Uterine sarcoma Endocrinopathy Fallopian tube cancer |
|
Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Mitosis Modulators Antimitotic Agents Antibiotics, Antineoplastic Pharmacologic Actions |
Adnexal Diseases Neoplasms Neoplasms by Site Therapeutic Uses Tubulin Modulators Antineoplastic Agents, Phytogenic |
