Femara (Letrozole) Versus Placebo for Patients With Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

• Status: Withdrawn
• Trial end date: 2008-09-01
• Target enrollment: 0
• Participant gender: Female

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 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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborator: Novartis Pharmaceuticals
• Treatments: Letrozole

Criteria

Inclusion Criteria:

1. 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.

2. All patients must have had appropriate surgery with appropriate tissue available for histologic evaluation to confirm diagnosis and stage.

3. 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.

4. 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.

5. Patients willing to sign informed consent to participate in study for 5 years or until first recurrence.

Exclusion Criteria:

1. Patients with any evidence of metastatic disease after completion of surgery and first line chemotherapy

2. Patients with low grade ovarian cancer histology.

3. If chemotherapy initiated greater than 8 weeks after primary surgery or completed more than 8 weeks prior to treatment start.

4. Patients that received neoadjuvant chemotherapy.

5. Patients taking any form of HRT and/or CAM products (i.e. phytoestrogens, etc.)

6. Patients with history of prothrombic clotting disorders (i.e PE or DVT).

7. 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

8. Patients with severe concomitant disease which would place patient at unusual risk or confound the results of the trial.