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

NCT00634894 | Withdrawn Phase 2 DMC

• 1 other identifier: 2006-0689
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Ovarian Cancer; Fallopian Tube Cancer; Peritoneal Cancer

Keywords

Ovarian Cancer; Fallopian Tube Cancer; Peritoneal Cancer; Femara; Letrozole; Placebo

Outcome Measures

Primary Outcomes (1)

• Median Progression-free survival (PFS): Time to progression or death from complete response (CR)

  PFS defined as time to earliest occurrence of local or distant recurrence or clinically significant elevation in CA-125. Biochemical progression is defined as two serially rising serum values of CA-125 greater than or equal to two times the upper limits of normal (ULN \>35 U/ML) performed at least one week apart, regardless of CT scan results.

  Assessed after 12 weeks of therapy, and followed for 36 months post-treatment

Study Arms (2)

Femara

EXPERIMENTAL

Drug: Femara

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Femara DRUG

2.5 mg by mouth daily x 12 weeks

Also known as: Letrozole

Femara

Placebo DRUG

Placebo capsule by mouth daily x 12 weeks

Placebo

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Novartis Pharmaceuticals: collaborator

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center

MeSH Terms

Conditions

Ovarian Neoplasms; Fallopian Tube Neoplasms

Interventions

Letrozole

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Fallopian Tube Diseases

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Judith Wolf, MD

  UT MD Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2008
• First Posted: March 13, 2008
• Study Start: March 1, 2008
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: April 20, 2016

Record last verified: 2009-09

Locations

US (1)