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

Purpose

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
Ovarian Cancer Fallopian Tube Cancer Peritoneal Cancer	Drug: Femara Drug: Placebo	Phase II

MedlinePlus related topics:

Cancer Ovarian Cancer

ChemIDplus related topics:

Letrozole

U.S. FDA Resources

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

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

The goal of this clinical research study is to learn if taking Femara (letrozole) after surgery and chemotherapy treatment for ovarian, fallopian tube, or peritoneal cancer will delay or prevent the cancer from coming back. [ Time Frame: 17 Months ] [ Designated as safety issue: No ]

Estimated Enrollment:	50
Study Start Date:	March 2008
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Femara	Drug: Femara 2.5 mg by mouth daily x 12 weeks
2: Placebo Comparator Placebo Capsule	Drug: Placebo Placebo capsule by mouth daily x 12 weeks

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Eligibility

Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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 Criteria:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00634894

Contacts


Contact: Judith Wolf, MD	713-792-7310

Locations


United States, Texas
	U.T.M.D. Anderson Cancer Center	Recruiting
	Houston, Texas, United States, 77030
	Principal Investigator: Judith Wolf, MD

Sponsors and Collaborators

M.D. Anderson Cancer Center

Novartis

Investigators


Principal Investigator:	Judith Wolf, MD	U.T.M.D. Anderson Cancer Center

More Information

Responsible Party:	U.T.M.D. Anderson Cancer Center ( Judith Wolf, MD/Associate Professor )
Study ID Numbers:	2006-0689
First Received:	March 6, 2008
Last Updated:	March 6, 2008
ClinicalTrials.gov Identifier:	NCT00634894
Health Authority:	United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:

Ovarian Cancer

Fallopian Tube Cancer

Peritoneal Cancer

Femara

Letrozole

Placebo

Study placed in the following topic categories:

Ovarian cancer

Ovarian Neoplasms

Gonadal Disorders

Genital Neoplasms, Female

Endocrine System Diseases

Letrozole

Urogenital Neoplasms

Ovarian Diseases

Fallopian Tube Neoplasms

Fallopian Tube Diseases

Genital Diseases, Female

Fallopian tube cancer

Endocrinopathy

Endocrine Gland Neoplasms

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Site

Molecular Mechanisms of Pharmacological Action

Antineoplastic Agents

Therapeutic Uses

Enzyme Inhibitors

Aromatase Inhibitors

Pharmacologic Actions

Adnexal Diseases

ClinicalTrials.gov processed this record on September 23, 2008

Sponsors and Collaborators:	M.D. Anderson Cancer Center Novartis
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00634894