Clinical trial NCT00630110: Phase 1/2 Study of Vascular Disrupting Agent NPI-2358 + Docetaxel in Patients With Advanced Non-Small Cell Lung Cancer
Official title: Study of the Vascular Disrupting Agent NPI-2358 in Combination With Docetaxel in Patients With Advanced Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Cancer
Keywords: Non Small Cell Lung
Lead sponsor: Nereus Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2008-03-06
Enrollment: 172
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 is a clinical trial examining the vascular disrupting agent NPI-2358 combined with docetaxel in patients with advanced non-small cell lung cancer (NSCLC). The formation of new blood vessels (angiogenesis) is an important component of tumor growth, vascular disrupting agents are intended to target the differences between these tumor blood vessels and the blood vessels in normal tissues.

Detailed description: This is a clinical trial examining the vascular disrupting agent NPI-2358 combined with docetaxel in patients with advanced non-small cell lung cancer (NSCLC). The formation of new blood vessels (angiogenesis) is an important component of tumor growth, vascular disrupting agents are intended to target the differences between these tumor blood vessels and the blood vessels in normal tissues. There are indications of advantages in combining vascular disrupting agents with standard agents in the treatment of advanced non-small cell lung cancer (NSCLC).

Eligibility criteria: Inclusion Criteria:

* Male and females ≥ 18 years of age
* ECOG performance status ≤ 1
* Pathologically or histologically confirmed advanced non-small cell lung cancer (unresectable Stage IIIb or IV) that has progressed after treatment with at least one chemotherapy regimen; measurable disease is not required for enrollment into this trial
* All Adverse Events of any prior chemotherapy, surgery, or radiotherapy, must have resolved to Grade ≤ 2
* Signed informed consent

Exclusion Criteria:

* Administration of certain chemotherapy, biological, immunotherapy, radiation therapy, surgery or investigational agent within specified time frames
* Significant cardiac history
* Prior treatment with tumor vascular disruptive agents
* Seizure disorder
* Brain metastases
* Active uncontrolled bacterial, viral, or fungal infection, requiring systemic therapy
* Known infection with human immunodeficiency virus (HIV), or active hepatitis A, B, or C
* Patients with a prior hypersensitivity reaction to product components
* Pregnant or breast-feeding women.
* Concurrent, active second malignancy for which the patient is receiving therapy, excluding basal cell carcinoma of the skin or carcinoma in situ of the cervix
* Unwilling or unable to comply with procedures required in this protocol

Primary outcomes:
measure: Compare overall survival of patients treated with docetaxel to patients treated with docetaxel + NPI-2358
timeFrame: Continuous
Secondary outcomes:
measure: Compare response rate, duration of response, 6-month survival, progression free survival and safety.
timeFrame: Continuous
measure: Pharmacokinetics
timeFrame: Continuous
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic
state: Arizona
city: Encinitas
country: United States
facility: San Diego Pacific Oncology & Hematology Associates
state: California
city: San Diego
country: United States
facility: University San Diego Moores Cancer Center
state: California
city: San Diego
country: United States
facility: Kaiser Permanente
state: California
city: Santa Monica
country: United States
facility: Premiere Oncology
state: California
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Detroit
country: United States
facility: Karmanos Cancer Institute
state: Michigan
city: San Antonio
country: United States
facility: University Texas Health Science Center at San Antonio (CTRC)
state: Texas
city: Bahia Blanca
country: Argentina
facility: Policlinica Privada Instituto de Medicina Nuclear
city: Capital Federal
country: Argentina
facility: Hospital Britanico
city: Cordoba
country: Argentina
facility: Instituto Oncologico De Cordoba
city: Cordoba
country: Argentina
facility: Clinica Universitaria Privada Reina Fabiola
city: Rosario
country: Argentina
facility: Caici Centro de Asistencia e Investigacion Clinica Integral
city: Rosario
country: Argentina
facility: Hospital del Centrenario
city: South Brisbane
country: Australia
facility: Mater Adult Hospital
state: Queensland
city: Bendigo
country: Australia
facility: Bendigo Health Care Group
state: Victoria
city: Nedlands
country: Australia
facility: Sir Charles Gairdner Hospital
state: Western Australia
city: Barretos
country: Brazil
facility: Fundacap Pip XII Hospital do Cancer de Barretos
city: Curitiba
country: Brazil
facility: Hospital Erasto Gaertner Liga do Combate as Cancer
city: Ijui
country: Brazil
facility: Associacao Hospital de Caridade Ijui
city: Porte Alegre
country: Brazil
facility: Hospital Sao Lucas
city: Porto Alegre
country: Brazil
facility: Hospital de clinicas de Porto Alegre
city: Porto Alegre
country: Brazil
facility: Clinionco-Clinica de Oncologia de Porto Alegre
city: Sao Paulo
country: Brazil
facility: Hosp.das Clinicas da Univ.de Sao Paulo
city: Sao Paulo
country: Brazil
facility: Instituto do Cancer Aenaldo Vieira de Carvahlo
city: Santiago
country: Chile
facility: Instituto Nacional del Cancer Oncology
city: Valparaiso
country: Chile
facility: Hospital Carlos Van Buren
city: Kolkata
country: India
facility: Chittaranjan National Cancer Institute
state: W. Bengal
city: Bangalore
country: India
facility: Kidwai Memorial Institute of Oncology
city: Chennai
country: India
facility: Apollo Speciality Hospital
city: Hyderabad
country: India
facility: Apollo Hospital
city: Jaipur
country: India
facility: SEAROC Cancer Centre S.K. Soni Hospital
city: Kolkata
country: India
facility: Subodh Mitra Cancer Hospital & Research Centre
city: Mumbai
country: India
facility: Tata Memorial Hospital
city: Pune
country: India
facility: Ruby Hall Clinic
city: Vishakhapatnam
country: India
facility: Andhra Medical College
Study officials:
affiliation: Chief Medical Officer, Nereus Pharmaceuticals, Inc
name: Matthew A Spear, MD
role: STUDY_DIRECTOR
References: