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Sponsors and Collaborators: |
M.D. Anderson Cancer Center Novartis Pharmaceuticals |
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Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00634894 |
Primary Objective:
1. Evaluate the efficacy of letrozole to increase the duration of progression-free survival (defined as time to earliest occurrence of local or distant recurrence or clinically significant elevation in CA-125) when used as adjuvant treatment after completion of primary surgery and first line platinum containing chemotherapy in patients with optimally debulked (< 1 cm residual disease) stage IIA-IIIC ovarian, fallopian tube, or primary peritoneal cancer.
Secondary Objective:
1. Observe the incidence of local and distant recurrences.
Condition | Intervention | Phase |
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Ovarian Cancer Fallopian Tube Cancer Peritoneal Cancer |
Drug: Femara Drug: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase II, Double-Blinded, Randomized Evaluation of Femara (Letrozole) Versus Placebo for Adjuvant Treatment After Completion of First-Line Chemotherapy for Patients With Optimally Debulked and Chemoresponsive Ovarian, Fallopian Tube, or Primary Peritoneal Cancer |
Enrollment: | 0 |
Study Start Date: | March 2008 |
Study Completion Date: | September 2008 |
Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Femara
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Drug: Femara
2.5 mg by mouth daily x 12 weeks
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2: Placebo Comparator
Placebo Capsule
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Drug: Placebo
Placebo capsule by mouth daily x 12 weeks
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Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients must have completed primary treatment within the past 8 weeks and received at least 5 cycles and not more than 8 cycles of a platinum (IV or IP) and paclitaxel or docetaxel-based combination chemotherapy.
Patients must have no symptoms suggestive of persistent cancer.
Exclusion Criteria:
United States, Texas | |
U.T.M.D. Anderson Cancer Center | |
Houston, Texas, United States, 77030 |
Principal Investigator: | Judith Wolf, MD | U.T.M.D. Anderson Cancer Center |
Responsible Party: | U.T.M.D. Anderson Cancer Center ( Judith Wolf, MD/Associate Professor ) |
Study ID Numbers: | 2006-0689 |
Study First Received: | March 6, 2008 |
Last Updated: | March 13, 2009 |
ClinicalTrials.gov Identifier: | NCT00634894 History of Changes |
Health Authority: | United States: Institutional Review Board |
Ovarian Cancer Fallopian Tube Cancer Peritoneal Cancer |
Femara Letrozole Placebo |
Fallopian Tube Cancer Ovarian Neoplasms Digestive System Neoplasms Gonadal Disorders Adjuvants, Immunologic Genital Neoplasms, Female Endocrine System Diseases Letrozole Urogenital Neoplasms Ovarian Diseases Abdominal Neoplasms |
Fallopian Tube Neoplasms Genital Diseases, Female Digestive System Diseases Peritoneal Diseases Ovarian Cancer Gastrointestinal Neoplasms Endocrinopathy Peritoneal Neoplasms Aromatase Inhibitors Endocrine Gland Neoplasms |
Molecular Mechanisms of Pharmacological Action Gonadal Disorders Antineoplastic Agents Urogenital Neoplasms Letrozole Ovarian Diseases Genital Diseases, Female Neoplasms by Site Therapeutic Uses Peritoneal Diseases Aromatase Inhibitors Endocrine Gland Neoplasms Ovarian Neoplasms |
Digestive System Neoplasms Genital Neoplasms, Female Endocrine System Diseases Enzyme Inhibitors Abdominal Neoplasms Fallopian Tube Neoplasms Pharmacologic Actions Adnexal Diseases Fallopian Tube Diseases Neoplasms Digestive System Diseases Peritoneal Neoplasms |