Status:
WITHDRAWN
Femara (Letrozole) Versus Placebo for Patients With Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
Novartis Pharmaceuticals
Conditions:
Ovarian Cancer
Fallopian Tube Cancer
Eligibility:
FEMALE
Phase:
PHASE2
Brief Summary
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 si...
Detailed Description
THE STUDY DRUG: Letrozole is designed to block the enzyme that makes estrogen in post-menopausal women. By interfering with the production of estrogen made by the enzyme, letrozole decreases the tota...
Eligibility Criteria
Inclusion
- Patients with optimally debulked (\< 1 cm residual disease) stage IIA-IIIC ovarian, fallopian tube, or primary peritoneal cancer that have achieved a complete clinical response (CR) to first-line surgery and chemotherapy.
- All patients must have had appropriate surgery with appropriate tissue available for histologic evaluation to confirm diagnosis and stage.
- 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.
- Patient must have a CT or MRI scan of the abdomen/pelvis with no evidence of metastatic disease and a normal CA-125 (\< 35 Units/mL) following primary therapy.
- Patients willing to sign informed consent to participate in study for 5 years or until first recurrence.
Exclusion
- Patients with any evidence of metastatic disease after completion of surgery and first line chemotherapy
- Patients with low grade ovarian cancer histology.
- If chemotherapy initiated greater than 8 weeks after primary surgery or completed more than 8 weeks prior to treatment start.
- Patients that received neoadjuvant chemotherapy.
- Patients taking any form of HRT and/or CAM products (i.e. phytoestrogens, etc.)
- Patients with history of prothrombic clotting disorders (i.e PE or DVT).
- Patients with history of malignant disease within past 10 years except for squamous or basal cell carcinoma of the skin or carcinoma in situ of the cervix, adequately cone biopsied
- Patients with severe concomitant disease which would place patient at unusual risk or confound the results of the trial.
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00634894
Start Date
March 1 2008
End Date
September 1 2008
Last Update
April 20 2016
Active Locations (1)
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1
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030