Clinical trial NCT00966914: Phase 3 Study of Tavocept Versus Placebo in Patients With Newly Diagnosed or Relapsed Advanced Primary Adenocarcinoma of the Lung Treated With Docetaxel or Paclitaxel Plus Cisplatin
Official title: Randomized, Multicenter, Double-blind, Phase 3 Trial of Tavocept Versus Placebo in Patients With Newly Diagnosed or Relapsed Advanced Primary Adenocarcinoma of the Lung Treated With Docetaxel or Paclitaxel Plus Cisplatin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Non-small Cell Lung Cancer
Lead sponsor: BioNumerik Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Lantern Pharma Inc. became Sponsor of Tavocept (BNP7787) IND 051014 as of March 26, 2019.
First posted: 2009-08-27
Enrollment: 540
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: Tavocept is an investigational drug that is being developed to see if it can increase the survival of patients who are being treated with chemotherapy as well as to see if it can prevent or reduce side effects of chemotherapy. This research study is aimed at trying to find out if people with advanced adenocarcinoma of the lung who are treated with a standard combination of chemotherapy drugs will live longer if they are also treated with an investigational drug called "Tavocept." Another objective of this research study is to find out whether or not Tavocept helps to prevent or reduce side-effects like kidney damage, anemia, and nausea and vomiting that can occur with these drug combinations. The drug combinations that will be used in this research study will include either paclitaxel and cisplatin, or docetaxel and cisplatin. These drug combinations are approved to be used to treat people with advanced NSCLC. Every patient on this research study will be treated with standard chemotherapy for primary NSCLC in the form of either docetaxel or paclitaxel (these will be recommended by your research study doctor), which will be given in combination with cisplatin.


Eligibility criteria: Inclusion Criteria:

* Confirmed histopathological diagnosis of inoperable advanced primary adenocarcinoma (including bronchioalveolar cell carcinoma) of the lung
* No prior systemic treatment for non-small cell lung cancer including chemotherapy, immunotherapy, hormonal therapy, targeted therapies or investigational drugs

Exclusion Criteria:

* Small cell, squamous cell, large cell or undifferentiated or any form of mixed (eg, small cell and adenocarcinoma or squamous and adenocarcinoma) histopathological or cytological diagnosis of primary lung cancer
* Adenocarcinoma arising from primary sites other than the lung
* Patients without documented Stage 4 disease (in accordance with AJCC TMM Staging System 7th edition)
* Patients with unstable CNS mets within 21 days before randomization

Primary outcomes:
measure: Overall Survival
timeFrame: throughout study
Secondary outcomes:
measure: Progression Free Survival
timeFrame: Every 2 cycles during study treatment then every 6-8 weeks after going off study for up to 6 months, or until progression or initiation of further treatment
measure: Incidence of 30% or greater decrease in the calculated creatinine clearance relatively to baseline
timeFrame: throughout the study
measure: Incidence of NCI-CTCAE grade 2,3, or 4 anemia
timeFrame: throughout the study
measure: Proportion of patients having no impact of chemotherapy-induced emesis on daily life
timeFrame: throughout the study
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Columbia
country: United States
state: Missouri
city: Philadelphia
country: United States
state: Pennsylvania
city: Germantown
country: United States
state: Tennessee
city: Gabrovo
country: Bulgaria
city: Plovidv
country: Bulgaria
city: Sofia
country: Bulgaria
city: Sofia
country: Bulgaria
city: Veliko Tarnovo
country: Bulgaria
city: Elblag
country: Poland
city: Szczecin
country: Poland
city: Torun
country: Poland
city: Warsaw
country: Poland
city: Brasov
country: Romania
city: Bucharest
country: Romania
city: Cluj Napoca
country: Romania
city: Craiova
country: Romania
city: Timisoara
country: Romania
city: Arkangelsk
country: Russian Federation
city: Chelyabinsk
country: Russian Federation
city: Ekaterinburg
country: Russian Federation
city: Krasnodar Krai
country: Russian Federation
city: Krasnodar
country: Russian Federation
city: Kursk
country: Russian Federation
city: Moscow
country: Russian Federation
city: Novosibirsk
country: Russian Federation
city: Omsk
country: Russian Federation
city: Saint Petersburg
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: Stavropol Krai
country: Russian Federation
city: Stavropol
country: Russian Federation
city: Tambov
country: Russian Federation
city: Voronezh
country: Russian Federation
city: Yaroslavl
country: Russian Federation
city: Chernihiv
country: Ukraine
city: Dnipropetrovsk
country: Ukraine
city: Donetsk
country: Ukraine
city: Kharkiv
country: Ukraine
city: Kherson
country: Ukraine
city: Sumy
country: Ukraine
city: Uzhorod
country: Ukraine
city: Zaporiahya
country: Ukraine
Study officials:
References: