Study to Evaluate Treatment Customized According to RAP80 and BRCA1 in Patients With Advanced Lung Carcinoma

Non Small Cell Lung Cancer Clinical Trial

— BREC  

Official title:

Multicenter Phase III, Randomized Study to Evaluate Treatment Customized According to RAP80 and BRCA1 Assessment in Patients With Advanced Non-small-cell Lung Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00617656
• Other study ID #: GECP-BREC
• Secondary ID: 2007-004278-20
• Status: Terminated
• Phase: Phase 3
• Start date: February 2008
• Est. completion date: April 2015

Study information

• Verified date: January 2024
• Source: Spanish Lung Cancer Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Primary objective:

· Progression free survival.

Secondary objectives:

• Assess Overall survival of both treatment groups.

• Assess Tumor response rate using RECIST criteria

• Assess Toxicity profile of patients enrolled in the study.

• Exploratory evaluation of potential genetic markers of response or resistance to chemotherapy.

Description:

Study population:

Patients with advanced non-small-cell lung cancer who have not received treatment for the disease at this stage and who have a good performance status (ECOG 0-1) and measurable disease (at least one target lesion according to RECIST criteria).

Duration of treatment:

Six chemotherapy cycles will be given. The duration of every cycle will be 21 days. If the treatment is beneficial, it may be prolonged to a total of 8 cycles at the discretion of the investigator.

Calendar and planned finalization date:

The approximate duration of the study is 3 years of recruitment followed by 1 year of follow-up.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 382
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

INCLUSION CRITERIA:

1. Patients age 18 years or more.

2. Histologically confirmed diagnosis of non-small-cell lung carcinoma.

3. Only patients with advanced disease defined as stage IV or IIIB with or without pleural effusion will be included. In the event of IIIB disease without pleural effusion those patients, who for some reason (respiratory disease, large radiation volume...) may not be candidates to have chemotherapy and radiotherapy treatment and may only be treated with chemotherapy, will be considered.

4. Tumor specimen available (according to the criterion of the specimen-processing laboratory) for the analysis of RAP80 and BRCA1 expression in mRNA.

5. A measurable lesion, as defined by RECIST criteria.

6. Karnofsky score 80% or more (ECOG < 2).

7. No previous treatment with chemotherapy or other agents for disseminated disease. Chemotherapy is allowed if the patient's initial diagnosis is limited disease and the patient has received adjuvant or neoadjuvant treatment, as long as a minimum of 6 months has passed since the end of the adjuvant and/or neo-adjuvant chemotherapy.

8. Patients with cerebral disease may be included without any time limitations after holocranial irradiation or complementary antiedema treatment, as long as there is correct control of the clinical symptoms arising from the brain disease or is symptomatic.

9. Patients with the following hematologic values:

ANC = 1.5 x 109/L Hb = 10 g/dl Platelets = 100 x 109/L

10. Patients with the following biochemical values:

Bilirubin = 1.5 mg/dL AST and ALT < 1.5 upper limit of normality Creatinine clearance = 60 ml/min.

11. Patients of childbearing age of either sex must use effective contraceptive methods (barrier methods or other birth control methods) before entering the study and while participating in the study.

12. Patients should sign an informed consent form before inclusion in the study that specifies that the clinical trial treatment entails consent for the analysis of biological specimens of tumor and blood.

13. Patients must be available for clinical follow-up.

EXCLUSION CRITERIA

1. Previous chemotherapy treatment, except the supposition reflected in inclusion criterion 7.

2. Patients diagnosed of another neoplasm, with the exception of cervical carcinoma in situ, treated squamous cell carcinomas or superficial bladder tumors (Ta and TIS), or other malignant tumors that have received curative treatment within the last 5 years before inclusion in the study.

3. Patients with serious active bacterial or fungal infective processes from a clinical vantage point (= grade 2 of NCI-CTC, Version 3).

4. Patients who have received an investigational medicinal product in the 21 days before inclusion in the study.

5. Patients with HIV infection, HCV infection, coronary artery disease or uncontrolled arrhythmia, uncontrolled cerebrovascular disease, or other clinical conditions that, in the judgment of the investigator, contraindicate the patient's participation in the study.

6. Patients who are pregnant or breastfeeding. Women of childbearing age must have a negative pregnancy test performed within 7 days before the onset of treatment.

7. Substance abuse and clinical, psychological or social conditions that can undermine the validity of the informed consent or protocol compliance.

8. Patients who present any contraindication or suspected allergy to the products under investigation in the study

9. Impossibility to comply with chemotherapy treatment due to cultural or geographic circumstances.

10. Significant weight loss (= 10% of body weight) in the 6 weeks before inclusion in the study.

11. Any condition that is unstable or could endanger the patient's safety and/or the patient's compliance with the study.

12. Contraindication for steroid use.

Related Conditions & MeSH terms

• BRCA1 Mutation
• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non Small Cell Lung Cancer

Intervention

Drug:
• Cisplatin, Docetaxel
Docetaxel 75 mg/m2 and cisplatin 75 mg/m2, both on day 1, every 21 days. Total number of cycles: 6
• Gemcitabine, Cisplatin
Gemcitabine 1250 mg/m2, days 1 and 8, and Cisplatin 75 mg/m2, day 1. 21-day cycles. Total number of cycles: 6
• Docetaxel, Cisplatin
Docetaxel 75 mg/m2 and Cisplatin 75 mg/m2, both administered on day 1, every 21 days. Total number of cycles: 6
• Docetaxel
Docetaxel 75 mg/m2, day 1. 21-day cycles. Total number of cycles: 6

Locations

Country	Name	City	State
Spain	H. Juan Canalejo	A Coruña
Spain	H. Santiago de Compostela	A Coruña
Spain	H. Virgen de los Lirios	Alcoi	Alicante
Spain	F.H.Alcorcón	Alcorcon	Madrid
Spain	H. Gral. Alicante	Alicante
Spain	H. Torrecárdenas	Almería
Spain	Hospital Torrecárdenas	Almería
Spain	H. Germans Trias i Pujol	Badalona	Barcelona
Spain	Hospital de Cruces	Barakaldo	Bizkaia
Spain	H. Clinic i Provincial	Barcelona
Spain	H. Duran i Reynals-ICO	Barcelona
Spain	H. Universitario Quirón Dexeus	Barcelona
Spain	Hospital de La Santa Creu I Sant Pau	Barcelona
Spain	Hospital del Mar	Barcelona
Spain	Hospital de Basurto	Bilbao	Vizcaya
Spain	Hospital General Yagüe	Burgos
Spain	Hospital Ernest Lluch	Calatayud	Zaragoza
Spain	H. Provincial de Castellón	Castelló
Spain	Hospital Reina Sofía	Cordoba	Córdoba
Spain	Hospital Universitari de Girona Dr. Josep Trueta	Girona
Spain	Hospital Virgen de las Nieves	Granada
Spain	Hospital Ciudad de Jaén	Jaén
Spain	H. Severo Ochoa	Leganés	Madrid
Spain	Fundación Jiménez Díaz	Madrid
Spain	H. de la Princesa	Madrid
Spain	H.U. Puerta de Hierro	Madrid
Spain	Hospital Clínico San Carlos	Madrid
Spain	Hospital Gregorio Marañon	Madrid
Spain	Hospital Carlos Haya	Málaga
Spain	Hospital Virgen de la Victoria	Málaga
Spain	Hospital D'Althaia	Manresa	Barcelona
Spain	Hospital de Mataró	Mataró	Barcelona
Spain	Hospital Morales Messeguer	Murcia
Spain	H. Son Llátzer	Palma De Mallorca
Spain	Hospital Son Dureta/ Ses Espases	Palma De Mallorca
Spain	Clinica Quiron	Pozuelo De Alarcón	Madrid
Spain	Hospital Universitario Quirón Madrid	Pozuelo De Alarcón	Madrid
Spain	Hospital nuestra señora de Valme	Sevilla
Spain	H. Gen. Univ. Valencia	Valencia
Spain	Hospital Arnau de Vilanova	Valencia
Spain	Hospital Clínico Universitario de Valencia	Valencia
Spain	H. General de Vic	Vic
Spain	H. Clínico Lozano Blesa	Zaragoza
Spain	Hospital Clínico Lozano Blesa	Zaragoza

Sponsors (1)

Lead Sponsor	Collaborator
Spanish Lung Cancer Group

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Survival	Defined as the length of time from the start of treatment to the date of the first documented progression of disease. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions	From the day of start of treatment until first documented progression or death due to any cause,up to 18 months.
Secondary	Overall Survival	Defined as the length of time from the start of the treatment that patients diagnosed with the disease are still alive.	From the date of start of the treatment until death or end of follow up, up to 18 months.

External Links

•   Web page of the sponsor where users can find more information about Fundación GECP studies