|
Combination Chemotherapy in Treating Patients With Endometrial Cancer, Fallopian Tube Cancer, or Sarcoma of the Female Reproductive Tract Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified health advice, visits or treatment with a real mD. We are not doctors. Always consult your doctor about Combination Chemotherapy in Treating Patients With Endometrial Cancer, Fallopian Tube Cancer, or Sarcoma of the Female Reproductive Tract conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Combination Chemotherapy in Treating Patients With Endometrial Cancer, Fallopian Tube Cancer, or Sarcoma of the Female Reproductive Tract Clinical research trials and Combination Chemotherapy in Treating Patients With Endometrial Cancer, Fallopian Tube Cancer, or Sarcoma of the Female Reproductive Tract healthcare trials happen in many of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new drugs. The purpose of the studies / projects is to solve particular human medical questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to discover cures for all varieties of conditions, such as Combination Chemotherapy in Treating Patients With Endometrial Cancer, Fallopian Tube Cancer, or Sarcoma of the Female Reproductive Tract. Combination Chemotherapy in Treating Patients With Endometrial Cancer, Fallopian Tube Cancer, or Sarcoma of the Female Reproductive Tract Clinical Trials and other clinical trials allow volunteers to have health treatment alternatives before they are available to the masses. Some times the human subjects obtain treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Combination Chemotherapy in Treating Patients With Endometrial Cancer, Fallopian Tube Cancer, or Sarcoma of the Female Reproductive Tract clinical trial. Test subjects oftentimes receive the most effective healthcare possible for their Combination Chemotherapy in Treating Patients With Endometrial Cancer, Fallopian Tube Cancer, or Sarcoma of the Female Reproductive Tract condition. Dangers are a reality, however, and may include extra or frequent physician visits, healthcare dangers (possibly life-jeopardising), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
|
|
|
|
|
|
|
Home > "C" Clinical Trials Conditions > Combination Chemotherapy in Treating Patients With Endometrial Cancer, Fallopian Tube Cancer, or Sarcoma of the Female Reproductive Tract  Combination Chemotherapy in Treating Patients With Endometrial Cancer, Fallopian Tube Cancer, or Sarcoma of the Female Reproductive Tract
Combination Chemotherapy in Treating Patients With Endometrial Cancer, Fallopian Tube Cancer, or Sarcoma of the Female Reproductive Tract
For Condition: stage 4 uterine sarcoma,Fallopian Tube Cancer,recurrent uterine sarcoma,Endometrial Stromal Sarcoma,uterine leiomyosarcoma,stage 4 endometrial cancer,uterine carcinosarcoma,ovarian sarcoma,recurrent endometrial cancer,ovarian carcinosarcoma
Status: Completed
Sponsor(s): National Cancer Institute (NCI) , Kaplan Cancer Center
Synopsis: 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.
Details: 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. PROTOCOL 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY 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 --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 --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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
FrancoMuggia, Study Chair, Kaplan Cancer Center
New York Presbyterian Hospital - Cornell Campus
New York City, New York, 10021
United States
Mount Sinai Medical Center, NY
New York City, New York, 10029
United States
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York City, New York, 10016
United States
Albert Einstein Comprehensive Cancer Center
Bronx, New York, 10461
United States
New York Medical College
Valhalla, New York, 10595
United States
Additional Information:
Study ID Numbers: CDR0000066300; NYU-9708,NCI-G98-1427,NYGOG-NY9708
Study Start Date: March 1997
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003334
Other Ovarian Carcinosarcoma Studies:
1. Chemotherapy in Treating Patients With Sarcoma of the Uterus
2. Thalidomide in Treating Patients With Recurrent or Persistent Carcinosarcoma of the Uterus
3. Radiation Therapy Compared With Combination Chemotherapy in Treating Patients With Cancer of the Uterus
4. Ifosfamide With or Without Paclitaxel in Treating Patients With Advanced, Refractory, or Recurrent Cancer of the Uterus
5. Topotecan in Treating Patients With Recurrent or Refractory Cancer of the Uterus
Related Studies:
Other ovarian carcinosarcoma Clinical Trials
Other New York Clinical Trials
Other New York City Clinical Trials
Combination Chemotherapy in Treating Patients With Endometrial Cancer, Fallopian Tube Cancer, or Sarcoma of the Female Reproductive Tract
|
|
|
|
|
|
|
|
