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

Withdrawn before enrolling · Phase 2 · Has a placebo group

Conditions studied: Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer

In brief

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.

Key facts

Study ID

NCT00634894

Run by

M.D. Anderson Cancer Center

People needed

0

Starts

2008-03-01

Expected to finish

2008-09-01

Last updated by the study team

2016-04-20

Who can join

Age: any. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• UT MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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