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Sponsors and Collaborators: |
Vanderbilt-Ingram Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00653328 |
RATIONALE: Drugs used in chemotherapy, such as atrasentan and doxorubicin hydrochloride liposome, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase II trial is studying giving atrasentan together with doxorubicin hydrochloride liposome as second-line therapy to see how well it works in treating patients with recurrent ovarian cancer, fallopian tube cancer, or peritoneal cancer.
Condition | Intervention | Phase |
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Fallopian Tube Cancer Ovarian Cancer Peritoneal Cavity Cancer |
Drug: atrasentan hydrochloride Drug: pegylated liposomal doxorubicin hydrochloride |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label |
Official Title: | A Phase II Study of Atrasentan (ABT-627) Plus Pegylated Liposomal Encapsulated Doxorubicin (DOXIL) in Patients With Recurrent Ovarian, Fallopian Tube, or Peritoneal Serous Papillary Adenocarcinoma Following Platinum + Taxane Therapy |
Estimated Enrollment: | 60 |
Study Start Date: | May 2003 |
Estimated Primary Completion Date: | September 2006 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study. Patients are stratified according to response to prior treatment with platinum-taxane (sensitive vs resistant).
Patients receive oral atrasentan hydrochloride once daily on days 1-28 and pegylated liposomal doxorubicin hydrochloride IV on day 1. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed at 30 days and every 2 months thereafter.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Study ID Numbers: | CDR0000584698, VU-VICC-GYN-0288, VU-VICC-020947 |
Study First Received: | April 3, 2008 |
Last Updated: | December 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00653328 |
Health Authority: | United States: Federal Government |
recurrent ovarian epithelial cancer fallopian tube cancer peritoneal cavity cancer |
Ovarian cancer Digestive System Neoplasms Ovarian Neoplasms Gonadal Disorders Genital Neoplasms, Female Endocrine System Diseases Urogenital Neoplasms Ovarian Diseases Ovarian epithelial cancer Abdominal Neoplasms Doxorubicin Fallopian Tube Neoplasms |
Recurrence Fallopian Tube Diseases Genital Diseases, Female Digestive System Diseases Peritoneal Diseases Gastrointestinal Neoplasms Endocrinopathy Fallopian tube cancer Peritoneal Neoplasms Adenocarcinoma Taxane Endocrine Gland Neoplasms |
Neoplasms Neoplasms by Site Antineoplastic Agents Therapeutic Uses |
Antibiotics, Antineoplastic Pharmacologic Actions Adnexal Diseases |