Clinical trial NCT00777179: Phase II of Zactima Maintenance for Locally Advanced or Metastatic Non-small-cell Lung Carcinoma (NSCLC) Following Platinum-doublet Chemotherapy
Official title: Randomized, Double-blinded, Placebo-controlled Phase II Study of Vandetanib (ZactimaTM) Maintenance for Locally Advanced or Metastatic Non-small-cell Lung Carcinoma (NSCLC) Following Platinum-doublet Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: NSCLC
Keywords: Vandetanib, NSCLC, Maintenance, Phase II
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2008-10-22
Enrollment: 117
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: This study is multicenter, randomized, double-blinded, placebo-controlled Phase II study comparing vandetanib (300mg daily) plus best supportive care (BSC) to placebo plus BSC as maintenance treatment in patients with locally advanced or metastatic NSCLC, who have received and responded to prior platinum-doublet systemic chemotherapy. The primary objective of the study is to compare the Progression Free Survival (PFS) rate at 3 months in locally advanced or metastatic NSCLC patients with or without vandetanib maintenance.


Eligibility criteria: Inclusion Criteria:

* Histologic or cytologic confirmation of locally advanced or metastatic NSCLC (IIIb-IV) at the time of original diagnosis.
* Completion of 4 cycles of chemotherapy of gemcitabine (1,000 or 1250mg/m\^2/day on day 1 and 8) and cisplatin (70-80mg/m\^2/day on day 1) every 3 weeks and have shown response, Complete Response(CR), Partial Response (PR) or stable disease (SD) by RECIST.
* WHO PS 0-1
* No prior radiotherapy to chest, immunotherapy or biologic therapy

Exclusion Criteria:

* Mixed small cell and non small-cell lung cancer history.
* Prior treatment with EGFR TKIs or VEGFR TKIs (prior treatment with cetuximab \[Erbitux\] or bevacizumab \[Avastin\] is not permitted.)
* Evidence of severe or uncontrolled systemic disease or any concurrent condition which in the investigator's opinion makes it undesirable for the patient to participate in the study or which would jeopardize compliance with the protocol.
* Radiation therapy within 4 weeks before the start of study therapy. Major surgery within 4 weeks, or incomplete healed surgical incision before starting study therapy.

Primary outcomes:
measure: Progression-free Survival (PFS) Rate at 3 Months
timeFrame: 12 weeks
Secondary outcomes:
measure: Progression-free Survival (PFS)
timeFrame: Performed at baseline, every 4 weeks until Week 12 following randomization and then every 8 weeks until objective disease progression.
measure: Overall Survival (OS)
timeFrame: Every 12 weeks unless the patient withdraws consent
measure: Disease of Response (DOR)
timeFrame: Performed at baseline, every 4 weeks until Week 12 following randomization and then every 8 weeks until objective disease progression.
measure: Objective Response Rate (ORR)
timeFrame: Performed at baseline, every 4 weeks until Week 12 following randomization and then every 8 weeks until objective disease progression.
Other outcomes:
Locations:
city: CheongJu
country: Korea, Republic of
facility: Research Site
state: Republic of Korea
city: Gyeonggi-do
country: Korea, Republic of
facility: Research Site
state: Republic of Korea
city: Gyeongsangnam-Do
country: Korea, Republic of
facility: Research Site
state: Republic of Korea
city: Incheon
country: Korea, Republic of
facility: Research Site
state: Republic of Korea
city: Seoul
country: Korea, Republic of
facility: Research Site
state: Republic of Korea
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: