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Femara (Letrozole) Versus Placebo for Patients With Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
This study has been terminated.
( The drug company sponsor has withdrawn support. )
First Received: March 6, 2008   Last Updated: March 13, 2009   History of Changes
Sponsors and Collaborators: M.D. Anderson Cancer Center
Novartis Pharmaceuticals
Information provided by: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00634894
  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

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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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: 6 Months ] [ Designated as safety issue: No ]

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
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

  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00634894

Locations
United States, Texas
U.T.M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Novartis Pharmaceuticals
Investigators
Principal Investigator: Judith Wolf, MD U.T.M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

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

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:
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on September 10, 2009