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Phase II Study of Doxil and Paclitaxel in Patients With Endometrial, Tubal, and Sarcomas of Gynecologic Origin


Phase 2
N/A
N/A
Not Enrolling
Female
Endometrial Cancer, Fallopian Tube Cancer, Ovarian Cancer, Sarcoma

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Trial Information

Phase II Study of Doxil and Paclitaxel in Patients With Endometrial, Tubal, and Sarcomas of Gynecologic Origin


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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Franco M. Muggia, MD

Investigator Role:

Study Chair

Investigator Affiliation:

New York University School of Medicine

Authority:

United States: Federal Government

Study ID:

CDR0000066300

NCT ID:

NCT00003334

Start Date:

March 1997

Completion Date:

Related Keywords:

  • Endometrial Cancer
  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Sarcoma
  • 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
  • Endometrial Neoplasms
  • Sarcoma, Endometrial Stromal
  • Ovarian Neoplasms
  • Fallopian Tube Neoplasms
  • Adenoma
  • Sarcoma

Name

Location

Albert Einstein Comprehensive Cancer CenterBronx, New York  10461
Mount Sinai Medical Center, NYNew York, New York  10029
New York Presbyterian Hospital - Cornell CampusNew York, New York  10021
NYU School of Medicine's Kaplan Comprehensive Cancer CenterNew York, New York  10016
New York Medical CollegeValhalla, New York  10595