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Sponsors and Collaborators: |
University of Medicine and Dentistry New Jersey Gynecologic Oncology Group National Cancer Institute (NCI) |
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Information provided by: | University of Medicine and Dentistry New Jersey |
ClinicalTrials.gov Identifier: | NCT00698620 |
This study is being done on women who have cancer of the endometrium (lining of the womb), that cannot be cured with surgery or radiation therapy. In a previous study, women with an advanced stage of endometrium cancer showed improved chances of survival after receiving chemotherapy. In advanced or recurrent endometrial cancer, the Gynecologic Oncology Group (GOG) has used chemotherapy with the drugs cisplatin, doxorubicin and paclitaxel to treat these patients. Additionally, other doctors have used the drugs carboplatin and paclitaxel to treat similar patients. Both of these treatments have been shown to shrink tumors in patients with endometrial cancer.
The purpose of this study is to find out whether treatment with the two-drug combination of carboplatin and paclitaxel is as good as the current standard three-drug combination of cisplatin, doxorubicin, and paclitaxel. Side effect information will also be analyzed to see if there are any differences between the two-drug and three-drug chemotherapy combinations with regard to ease of treatment and patient tolerance. Lastly, there are no known treatments for endometrial cancer that have been shown to be better than these two chemotherapy regimens.
Condition | Intervention | Phase |
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Endometrial Cancer |
Drug: paclitaxel Drug: doxorubicin Drug: cisplatin Drug: filgrastim |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Efficacy Study |
Official Title: | Randomized Phase III Trial Of Doxorubicin/Cisplatin/Paclitaxel And G-CSF Versus Carboplatin/Paclitaxel In Patients With Stage III & IV Or Recurrent Endometrial Cancer |
Estimated Enrollment: | 900 |
Study Start Date: | August 2003 |
Estimated Primary Completion Date: | January 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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I: Active Comparator
Patients receive doxorubicin IV over 15 minutes and cisplatin IV over 60-90 minutes on day 1; paclitaxel IV over 3 hours on day 2; and filgrastim (G-CSF) subcutaneously on days 3-12. Treatment repeats every 21 days for 7 courses in the absence of disease progression or unacceptable toxicity.
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Drug: paclitaxel
paclitaxel IV over 3 hours on day 1. Treatment repeats every 21 days for 7 courses in the absence of disease progression or unacceptable toxicity.
Drug: doxorubicin
Patients receive doxorubicin IV over 15 minutes on day 1
Drug: cisplatin
cisplatin IV over 60-90 minutes on day 1
Drug: filgrastim
filgrastim (G-CSF) subcutaneously on days 3-12
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II: Active Comparator
Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 7 courses in the absence of disease progression or unacceptable toxicity.
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Drug: paclitaxel
paclitaxel IV over 3 hours on day 1. Treatment repeats every 21 days for 7 courses in the absence of disease progression or unacceptable toxicity.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed endometrial carcinoma
At least 1 unidimensionally measurable lesion (for patients with stage III disease only)
PATIENT CHARACTERISTICS:
AGE
PRIOR CONCURRENT THERAPY:
BIOLOGIC THERAPY
Contact: Bernadette Cracchiolo, MD, MPH | 973-972-5055 | cracchbm@umdnj.edu |
Contact: Yasmeen S Barber, BA | 9739727789 | barberys@umdnj.edu |
United States, New Jersey | |
University of Medicine and Dentistry of New Jersey | Recruiting |
Newark, New Jersey, United States, 07101 | |
Contact: Yasmeen S Barber, BA 973-972-7789 barberys@umdnj.edu | |
Principal Investigator: Baernadette Cracchiolo, MD, MPH | |
Sub-Investigator: Debra Heller, MD | |
Sub-Investigator: Margarette Bryan, MD |
Study Chair: | David S. Miller, MD | Simmons Cancer Center |
Responsible Party: | Gynecologic Oncology Group ( DAVID SCOTT MILLER, M.D. Study Chair ) |
Study ID Numbers: | 0120040379 |
Study First Received: | June 12, 2008 |
Last Updated: | June 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00698620 History of Changes |
Health Authority: | United States: Institutional Review Board |
Genital Neoplasms, Female Uterine Diseases Urogenital Neoplasms Endometrial Cancer Antimitotic Agents Carboplatin Recurrence Doxorubicin Genital Diseases, Female |
Anti-Bacterial Agents Endometrial Neoplasms Cisplatin Radiation-Sensitizing Agents Paclitaxel Tubulin Modulators Uterine Neoplasms Antineoplastic Agents, Phytogenic |
Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Mitosis Modulators Physiological Effects of Drugs Genital Neoplasms, Female Uterine Diseases Urogenital Neoplasms Antimitotic Agents Antibiotics, Antineoplastic Pharmacologic Actions Doxorubicin |
Genital Diseases, Female Endometrial Neoplasms Neoplasms Neoplasms by Site Radiation-Sensitizing Agents Cisplatin Paclitaxel Therapeutic Uses Tubulin Modulators Uterine Neoplasms Antineoplastic Agents, Phytogenic |