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Sponsors and Collaborators: |
Wake Forest University National Cancer Institute (NCI) |
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Information provided by: | Wake Forest University |
ClinicalTrials.gov Identifier: | NCT00354601 |
RATIONALE: Drugs used in chemotherapy, such as docetaxel and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving docetaxel together with carboplatin may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving docetaxel together with capecitabine works in treating patients with recurrent or persistent ovarian epithelial cancer, fallopian tube cancer, or peritoneal cavity cancer.
Condition | Intervention | Phase |
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Fallopian Tube Cancer Ovarian Cancer Peritoneal Cavity Cancer |
Drug: capecitabine Drug: docetaxel |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment |
Official Title: | A Phase II Study of Weekly Docetaxel and Capecitabine for Persistent or Recurrent Platinum Resistant Epithelial Carcinoma of the Ovary, Fallopian Tube or Peritoneum |
Enrollment: | 2 |
Study Start Date: | January 2006 |
Study Completion Date: | July 2008 |
Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients receive docetaxel IV over 30 minutes on days 1, 8, and 15 and oral capecitabine twice daily on days 1-21. Treatment repeats every 28 days for ≥ 6 courses in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, on day 1 of each course, and then at completion of study treatment.
After completion of study treatment, patients are followed every 2-3 months.
PROJECTED ACCRUAL: A total of 39 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
DISEASE CHARACTERISTICS:
Diagnosis of 1 of the following:
Platinum-resistant disease, defined as 1 of the following:
PATIENT CHARACTERISTICS:
AST or ALT and alkaline phosphatase (AP) meeting 1 of the following criteria:
No clinically significant cardiac disease not well controlled with medication, including any of the following:
PRIOR CONCURRENT THERAPY:
United States, North Carolina | |
Wake Forest University Comprehensive Cancer Center | |
Winston-Salem, North Carolina, United States, 27157-1096 |
Study Chair: | Brigitte E. Miller, MD | Wake Forest University |
Responsible Party: | Wake Forest University Comprehensive Cancer Center ( Brigitte E. Miller ) |
Study ID Numbers: | CDR0000489036, CCCWFU-83203, CCCWFU-BG05-536, AVENTIS-CCCWFU-83203, ROCHE-CCCWFU-BG05-536 |
Study First Received: | July 19, 2006 |
Results First Received: | March 9, 2009 |
Last Updated: | June 2, 2009 |
ClinicalTrials.gov Identifier: | NCT00354601 History of Changes |
Health Authority: | United States: Food and Drug Administration |
fallopian tube cancer peritoneal cavity cancer recurrent ovarian epithelial cancer ovarian clear cell cystadenocarcinoma |
ovarian endometrioid adenocarcinoma ovarian mucinous cystadenocarcinoma ovarian serous cystadenocarcinoma ovarian undifferentiated adenocarcinoma |
Antimetabolites Cystadenocarcinoma, Serous Fallopian Tube Cancer Gonadal Disorders Urogenital Neoplasms Ovarian Diseases Carcinoma, Endometrioid Genital Diseases, Female Docetaxel Peritoneal Diseases Ovarian Cancer Endocrine Gland Neoplasms Capecitabine Ovarian Neoplasms |
Digestive System Neoplasms Genital Neoplasms, Female Endocrine System Diseases Abdominal Neoplasms Ovarian Epithelial Cancer Recurrence Fallopian Tube Neoplasms Carcinoma Digestive System Diseases Gastrointestinal Neoplasms Peritoneal Neoplasms Endocrinopathy Adenocarcinoma |
Antimetabolites Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Gonadal Disorders Antineoplastic Agents Urogenital Neoplasms Ovarian Diseases Genital Diseases, Female Docetaxel Neoplasms by Site Therapeutic Uses Peritoneal Diseases Endocrine Gland Neoplasms |
Capecitabine Ovarian Neoplasms Digestive System Neoplasms Genital Neoplasms, Female Endocrine System Diseases Abdominal Neoplasms Fallopian Tube Neoplasms Pharmacologic Actions Adnexal Diseases Fallopian Tube Diseases Neoplasms Digestive System Diseases Peritoneal Neoplasms |