Clinical trial NCT01814163: Observational Post-authorization Studies Carboplatin, Paclitaxel and Bevacizumab
Official title: Observational Studies to Explore the Relation Between Angiogenic Markers and the Treatment Response With Carboplatin, Paclitaxel and Bevacizumab in First Line of Advanced Non-small-cell Lung Cancer With Non- Squamous Histology
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nonsquamous Nonsmall Cell Neoplasm of Lung
Keywords: First line treatment
Non small cell lung cancer, non squamous
Lead sponsor: Spanish Lung Cancer Group
Sponsor class: OTHER
First posted: 2013-03-19
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with non-small cell lung cancer advanced unresectable, metastatic or recurrent, non-squamous and untreated with chemotherapy

Brief summary: This is a pharmacogenomic study with carboplatin, paclitaxel and bevacizumab as first line therapy in patients with non-squamous advanced non-small cell lung cancer.

Detailed description: This is a observational study prospectively followed post-authorization.

Eligibility criteria: Inclusion Criteria:

1. Patients should sign inform consent before inclusion in the study that specifies that the clinical treatment entails consent for the analysis of biological samples of tumor and blood.
2. Histologically confirmed diagnosis of advanced non small-cell lung carcinoma, non-squamous cell
3. Patients age 18 years or more
4. Patients will be candidates to received a first line of chemotherapy of carboplatin, paclitaxel and bevacizumab as the best therapeutic option.
5. Evidence of measurable disease per Response Evalutation Criteria in Solid tumors (RECIST)
6. Patients must be avalaible for clinical follow-up
7. Patients with the following hematologic/biochemical values:

   * Absolute Neutrophil Count ANC \> 1500/µl.
   * Platelets \> 100.000 /µl.
   * Hemoglobine \> 10 g/dl.
   * Bilirrubin \< 1.5 mg/dl.
   * Aspartate aminotransfereasa (AST) and Alanine transaminase (ALT) ≤ 3 x LSN, except in case of hepatic metastases: upper 5 x LSN
   * Creatinine clearance ≥ 45 ml/min.

Exclusion Criteria:

1. Previous treatment for advanced disease. Chemotherapy is allowed if the initial diagnosis of the patient is limited disease and the patient has received adjuvant or neadjuvant treatment
2. history of haemoptysis (defined as at least half a teaspoon's emission of red blood) in the 3 months prior to inclusion
3. evidence by CT of tumor cavitations, or tumours invading or abutting major blood vessels
4. Known or suspected brain metastases non-treated.
5. Major surgery within 28 days of starting treatment.
6. Minor surgery within 24 hours before starting the treatment.
7. Non-controlled hypertension (systolic \> 150 mm Hg and/or diastolic \> 100 mm Hg).
8. Patients with coronary disease or uncontrolled arrhytmia, uncontrolled cerebrovascular disease and other clinical conditions that, in judgment of the investigator, contraindicate the patient's participation in the study.
9. History or evidence of bleeding diathesis or hereditary coagulopathy.
10. Contraindication or suspected allergy to the products under investigation in the study:: paclitaxel, carboplatine or bevacizumab.
11. Patients who are pregnant or breasfeeding. Women of childbearing potencial must have a negative pregnancy test performed within 7 days before the onset of treatment.
12. Substance abuse of clinical, psychological or social conditions that can undermine the validity of the informed consent or protocol compliance

Primary outcomes:
measure: Correlation between angiogenesis markers and progression free survival.
timeFrame: 1 year
Secondary outcomes:
measure: Overal survival
timeFrame: 3 year
measure: Survival at 12 and 24 months
timeFrame: 12-24 months
measure: Objective response
timeFrame: 24 months
measure: Duration of response
timeFrame: 24 months
measure: Treatment security
timeFrame: 24 months
Other outcomes:
Locations:
city: Alicante
country: Spain
facility: H. Gen. Universitario Alicante
city: Castellón
country: Spain
facility: Hospital Provincial de Castellón
city: Elche (Alicante)
country: Spain
facility: Hospital General de Elche
city: l'Hospitalet (Barcelona)
country: Spain
facility: Hospital General de L'Hospitalet
city: Las Palmas
country: Spain
facility: Hospital Insular Gran Canaria
city: Madrid
country: Spain
facility: Clínica Quirón
city: Madrid
country: Spain
facility: Fundacion Jiménez Díaz
city: Madrid
country: Spain
facility: H. Clínico San Carlos
city: Madrid
country: Spain
facility: H. La Paz
city: Madrid
country: Spain
facility: Hospital Gregorio Marañon
city: Majadahonda (Madrid)
country: Spain
facility: Hospital Puerta de Hierro
city: Palma de Mallorca
country: Spain
facility: Clinica Rotger
city: Palma de Mallorca
country: Spain
facility: Hospital Son Espases
city: Santa Cruz de Tenerife
country: Spain
facility: Hospital Ntra Sra Candelaria
city: Santa Cruz de Tenerife
country: Spain
facility: Hospital Universitario Canarias
city: Valencia
country: Spain
facility: H. Gen. Univ. Valencia
city: Valencia
country: Spain
facility: Hospital Arnau de Vilanova
city: Valencia
country: Spain
facility: Hospital Dr. Peset
city: Valencia
country: Spain
facility: Hospital La Fe
city: Zaragoza
country: Spain
facility: Hospital Miguel Servet
Study officials:
affiliation: H. Gen. Univ.Alicante
name: Bartomeu Massutí, MD
role: STUDY_CHAIR
affiliation: H. Gen. Univ. Valencia
name: Carlos Camps, MD
role: STUDY_CHAIR
affiliation: H. La Paz
name: Javier de Castro, MD
role: STUDY_CHAIR
References: