Fulvestrant and Anastrozole as Consolidation Therapy in Postmenopausal Women With Advanced Non-small Cell Lung Cancer

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
University of Pittsburgh
Study ID
NCT00932152
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • fulvestrant (Faslodex) — DRUG
    Fulvestrant (Faslodex) IM 250 mg monthly after a loading dose of 500 mg on day 1 and 250 mg on day 15 of cycle 1.
  • anastrozole (Arimidex) — DRUG
    Anastrozole (Arimidex) 1 mg orally QD
  • Bevacizumab (Avastin) — DRUG
    Bevacizumab (Avastin) 15 mg/kg IV, every 21 days
  • Best supportive care — DRUG
    Subjects will not receive any chemotherapy for NSCLC nor will they received anti-cancer surgery, immunotherapy, radiotherapy or hormonal therapy. Among the therapies they may take are therapies considered acceptable include, but are not limited to, antibiotics, analgesics, antiemetics, thoracentesis, pleurodesis, blood transfusions, and/or nutritional support (enteral or parenteral

Study Details

This research study will test whether dual anti-estrogen therapy (anastrozole and fulvestrant) slows the time to when the cancer progresses.

Key Dates

First listed
Jul 3, 2009
Start date
Sep 30, 2010
Status verified
Sep 2017
Primary completion
Jan 31, 2013
Completion
Jan 31, 2013

Study Design

Enrollment
3 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Arm B, Group 1
    Best supportive care only: antibiotics, analgesics, antiemetics, thoracentesis, pleurodesis, blood transfusions, and/or nutritional support PRN
  • Active Comparator: Arm B, Group 2
    Best supportive care and Bevacizumab 15mg/kg every 21 days
  • Experimental: Arm A, Group 1
    Fulvestrant and anastrozole only
  • Experimental: Arm A, Group 2
    Fulvestrant, anastrozole and Bevacizumab

Primary Outcome Measure

To Evaluate the Progression-free Survival. [ Time Frame: 1.5 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Pittsburgh Cancer InstitutePittsburghPennsylvania15232-

Find similar trials in Pittsburgh, PA

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
University of Pittsburgh Cancer Institute· Pittsburgh, PA

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