Clinical trial NCT00312975: Randomized Study Of CP-675,206 or Best Supportive Care Immediately After Platinum-Based Therapy For Non-Small Cell Lung Cancer (NSCLC)
Official title: Phase 2 Randomized, Non-Comparative Study Of CP-675,206 Or Best Supportive Care Immediately Following First-Line, Platinum-Based Therapy In Patients With Stage IIIB (With Effusion) Or Stage IV Non-Small Cell Lung Cancer That Has Responded Or Remained Stable
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Carcinoma, Non-small-cell Lung
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2006-04-11
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this trial is to study how long patients can remain progression free when they receive CP-675,206, compared to how long patients can remain progression free when they receive best supportive care. If you choose to take part, you will be randomized to receive either CP-675,206 as maintenance therapy or best supportive care. Best supportive care means you will not receive any study drug or other treatment for your cancer. Best supportive care could include treatment with antibiotics, analgesic drugs (medicine for pain), blood transfusions or psychosocial and nutritional support, depending on your needs. You have a 50% chance of being randomized to receive CP-675,206.


Eligibility criteria: Inclusion Criteria:

* Stage IIIb (with effusion) or stage IV disease that has responded or remained stable after 6 cycles of a platinum containing 1st-line regimen
* Patients must be able to be randomized between 3 and no more than 6 weeks after the last dose of first-line therapy.

Exclusion Criteria:

* No other systemic therapy except 1st-line platinum based treatment
* Symptomatic or uncontrolled brain mets or uncontrolled pleural effusions.

Primary outcomes:
measure: The length of time until there is evidence of disease progression in patients treated with CP-675,206 and in patients receiving best supportive care.
timeFrame: 3 months to 2 years from randomization
Secondary outcomes:
measure: Survival
timeFrame: 2 years
measure: Levels of study drug in blood samples taken at specified time points.
timeFrame: up to 2 years
measure: Whether polymorphisms of certain genes influence safety.
timeFrame: up to 2 years
measure: Health-related quality of life outcomes.
timeFrame: up to 2 years
measure: Tumor response
timeFrame: up to 2 years
measure: Number of patients with adverse events as a measure of safety of CP-675,206 when administered to patients with NSCLC
timeFrame: up to 2 years
measure: Blood levels of any human anti-human antibody response
timeFrame: up to 2 years
measure: Immune response.
timeFrame: up to 2 years
measure: Efficacy
timeFrame: up to 2 years
Other outcomes:
Locations:
city: Bentonville
country: United States
facility: Research Site
state: Arkansas
city: Fayetteville
country: United States
facility: Research Site
state: Arkansas
city: Orange
country: United States
facility: Research Site
state: California
city: Danbury
country: United States
facility: Research Site
state: Connecticut
city: Atlanta
country: United States
facility: Research Site
state: Georgia
city: Lexington
country: United States
facility: Research Site
state: Kentucky
city: Alexandria
country: United States
facility: Research Site
state: Louisiana
city: New York
country: United States
facility: Research Site
state: New York
city: Oneida
country: United States
facility: Research Site
state: New York
city: Oswego
country: United States
facility: Research Site
state: New York
city: Syracuse
country: United States
facility: Research Site
state: New York
city: Syracuse
country: United States
facility: Research Site
state: New York
city: Canton
country: United States
facility: Research Site
state: Ohio
city: Philadelphia
country: United States
facility: Research Site
state: Pennsylvania
city: Calgary
country: Canada
facility: Research Site
state: Alberta
city: Calgary
country: Canada
facility: Research Site
state: Alberta
city: Edmonton
country: Canada
facility: Research Site
state: Alberta
city: Montreal
country: Canada
facility: Research Site
state: Quebec
city: Praha 8
country: Czech Republic
facility: Research Site
city: Tabor
country: Czech Republic
facility: Research Site
city: Usti nad Labem
country: Czech Republic
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Southampton
country: United Kingdom
facility: Research Site
state: Hampshire
city: London
country: United Kingdom
facility: Research Site
Study officials:
References: