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

NCT00617656 | Terminated Phase 3 Results DMC

• 2 other identifiers: GECP-BREC2007-004278-20
• Study Type: interventional
• Target: 382
• Locations: 1 country
• Sites: 44

Brief 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.

Conditions

Non Small Cell Lung Cancer; BRCA1 Mutation

Keywords

Lung Cancer; Chemotherapy; Personalized medicine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Overall Survival

  From the date of start of the treatment until death or end of follow up, up to 18 months.

Study Arms (4)

A: Control

ACTIVE COMPARATOR

Docetaxel 75 mg/m2 and cisplatin 75 mg/m2, both on day 1, every 21 days. Total number of cycles: 6

Drug: Cisplatin, Docetaxel

B1: Experimental group B1

EXPERIMENTAL

Low RAP expression and any levels of BRCA1 expression: Gemcitabine 1250 mg/m2, days 1 and 8, and Cisplatin 75 mg/m2, day 1. 21-day cycles. Total number of cycles: 6

Drug: Gemcitabine, Cisplatin

B2: Experimental group B2

EXPERIMENTAL

Intermediate or high RAP expression and low or intermediate BRCA1 expression: Docetaxel 75 mg/m2 and Cisplatin 75 mg/m2, both administered on day 1, every 21 days. Total number of cycles: 6

Drug: Docetaxel, Cisplatin

B3: Experimental group B3

EXPERIMENTAL

Intermediate or high RAP expression and high BRCA1 expression: Docetaxel 75 mg/m2, day 1. 21-day cycles. Total number of cycles: 6

Drug: Docetaxel

Interventions

Cisplatin, Docetaxel DRUG

Docetaxel 75 mg/m2 and cisplatin 75 mg/m2, both on day 1, every 21 days. Total number of cycles: 6

Also known as: Platinol, Taxotere

A: Control

Gemcitabine, Cisplatin DRUG

Gemcitabine 1250 mg/m2, days 1 and 8, and Cisplatin 75 mg/m2, day 1. 21-day cycles. Total number of cycles: 6

Also known as: Gemzar, Platinol

B1: Experimental group B1

Docetaxel, Cisplatin DRUG

Docetaxel 75 mg/m2 and Cisplatin 75 mg/m2, both administered on day 1, every 21 days. Total number of cycles: 6

Also known as: Taxotere, Platinol

B2: Experimental group B2

Docetaxel DRUG

Docetaxel 75 mg/m2, day 1. 21-day cycles. Total number of cycles: 6

Also known as: Taxotere

B3: Experimental group B3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients age 18 years or more.
• Histologically confirmed diagnosis of non-small-cell lung carcinoma.
• 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.
• Tumor specimen available (according to the criterion of the specimen-processing laboratory) for the analysis of RAP80 and BRCA1 expression in mRNA.
• A measurable lesion, as defined by RECIST criteria.
• Karnofsky score 80% or more (ECOG \< 2).
• 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.
• 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.
• Patients with the following hematologic values:
• ANC ≥ 1.5 x 109/L Hb ≥ 10 g/dl Platelets ≥ 100 x 109/L
• 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.
• 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.
• Patients must be available for clinical follow-up.

You may not qualify if:

• Patients with serious active bacterial or fungal infective processes from a clinical vantage point (= grade 2 of NCI-CTC, Version 3).
• 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.
• 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.
• Substance abuse and clinical, psychological or social conditions that can undermine the validity of the informed consent or protocol compliance.
• Patients who present any contraindication or suspected allergy to the products under investigation in the study
• Impossibility to comply with chemotherapy treatment due to cultural or geographic circumstances.
• Any condition that is unstable or could endanger the patient's safety and/or the patient's compliance with the study.
• Contraindication for steroid use.

Sponsors & Collaborators

• Spanish Lung Cancer Group: lead

Study Sites (44)

H. Virgen de los Lirios

Alcoy, Alicante, 03804, Spain

Location

H. Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

Location

Hospital D'Althaia

Manresa, Barcelona, 08243, Spain

Location

Hospital de Mataró

Mataró, Barcelona, 08304, Spain

Location

Hospital de Cruces

Barakaldo, Bizkaia, 48903, Spain

Location

Hospital Reina Sofía

Córdoba, Córdoba, 14004, Spain

Location

F.H.Alcorcón

Alcorcón, Madrid, 28922, Spain

Location

H. Severo Ochoa

Leganés, Madrid, 28911, Spain

Location

Clinica Quiron

Pozuelo de Alarcón, Madrid, 28223, Spain

Location

Hospital Universitario Quirón Madrid

Pozuelo de Alarcón, Madrid, Madrid, Spain

Location

Hospital de Basurto

Bilbao, Vizcaya, 48013, Spain

Location

Hospital Ernest Lluch

Calatayud, Zaragoza, 50299, Spain

Location

H. Juan Canalejo

A Coruña, 15006, Spain

Location

H. Santiago de Compostela

A Coruña, 15706, Spain

Location

H. Gral. Alicante

Alicante, 03010, Spain

Location

H. Torrecárdenas

Almería, 04009, Spain

Location

Hospital Torrecárdenas

Almería, 04009, Spain

Location

H. Clinic i Provincial

Barcelona, 08036, Spain

Location

H. Universitario Quirón Dexeus

Barcelona, 08036, Spain

Location

Hospital de La Santa Creu I Sant Pau

Barcelona, 08041, Spain

Location

H. Duran i Reynals-ICO

Barcelona, 08907, Spain

Location

Hospital del Mar

Barcelona, Spain

Location

Hospital General Yagüe

Burgos, 09005, Spain

Location

H. Provincial de Castellón

Castelló, 12002, Spain

Location

Hospital Universitari de Girona Dr. Josep Trueta

Girona, 17007, Spain

Location

Hospital Virgen de las Nieves

Granada, 18014, Spain

Location

Hospital Ciudad de Jaén

Jaén, 23007, Spain

Location

H. de la Princesa

Madrid, 28006, Spain

Location

H.U. Puerta de Hierro

Madrid, 28035, Spain

Location

Fundación Jiménez Díaz

Madrid, 28040, Spain

Location

Hospital Clínico San Carlos

Madrid, 28040, Spain

Location

Hospital Gregorio Marañon

Madrid, Spain

Location

Hospital Carlos Haya

Málaga, 29010, Spain

Location

Hospital Virgen de la Victoria

Málaga, 29010, Spain

Location

Hospital Morales Messeguer

Murcia, 30008, Spain

Location

Hospital Son Dureta/ Ses Espases

Palma de Mallorca, 07120, Spain

Location

H. Son Llátzer

Palma de Mallorca, 07198, Spain

Location

Hospital nuestra señora de Valme

Seville, 41014, Spain

Location

Hospital Clínico Universitario de Valencia

Valencia, 46010, Spain

Location

H. Gen. Univ. Valencia

Valencia, Spain

Location

Hospital Arnau de Vilanova

Valencia, Spain

Location

H. General de Vic

Vic, 08500, Spain

Location

Hospital Clínico Lozano Blesa

Zaragoza, 50009, Spain

Location

H. Clínico Lozano Blesa

Zaragoza, 59009, Spain

Location

Related Publications (2)

• Karachaliou N, Bracht JWP, Fernandez Bruno M, Drozdowskyj A, Gimenez Capitan A, Moran T, Carcereny E, Cobo M, Domine M, Chaib I, Ramirez JL, Camps C, Provencio M, Vergnenegre A, Lopez-Vivanco G, Majem M, Massuti B, Rosell R. Association of PALB2 Messenger RNA Expression with Platinum-Docetaxel Efficacy in Advanced Non-Small Cell Lung Cancer. J Thorac Oncol. 2019 Feb;14(2):304-310. doi: 10.1016/j.jtho.2018.10.168. Epub 2018 Nov 22.

  PMID: 30472259 DERIVED

• Moran T, Wei J, Cobo M, Qian X, Domine M, Zou Z, Bover I, Wang L, Provencio M, Yu L, Chaib I, You C, Massuti B, Song Y, Vergnenegre A, Lu H, Lopez-Vivanco G, Hu W, Robinet G, Yan J, Insa A, Xu X, Majem M, Chen X, de Las Penas R, Karachaliou N, Sala MA, Wu Q, Isla D, Zhou Y, Baize N, Zhang F, Garde J, Germonpre P, Rauh S, ALHusaini H, Sanchez-Ronco M, Drozdowskyj A, Sanchez JJ, Camps C, Liu B, Rosell R; Spanish Lung Cancer Group, the French Lung Cancer Group and the Comprehensive Cancer Centre of Drum Tower Hospital in Nanjing; Colinet B, De Greve J, Germonpre P, Chen H, Chen X, Du J, Gao Y, Hu J, Hu W, Kong W, Li L, Li R, Li X, Liu B, Liu J, Lu H, Qian X, Ren W, Song Y, Wang L, Wei J, Wen L, Wu Q, Xiao X, Xu X, Yan J, Yang J, Yang M, Yang Y, Yin J, You C, Yu L, Yue X, Zhang F, Zhang J, Zhou Y, Zhu L, Zou Z, Baize N, Bombaron P, Chouaid C, Dansin E, Fournel P, Fraboulet G, Gervais R, Hominal S, Kahlout S, Lecaer H, Lena H, LeTreut J, Locher C, Molinier O, Monnet I, Oliviero G, Robinet G, Schoot R, Thomas P, Vergnenegre A, Berchem G, Rauh S, Al Husaini H, Aparisi F, Arriola E, Ballesteros I, Barneto I, Bernabe R, Blasco A, Bosch-Barrera J, Bover I, Calvo de Juan V, Camps C, Carcereny E, Catot S, Cobo M, De Las Penas R, Domine M, Felip E, Garcia-Campelo MR, Garcia-Giron C, Garcia-Gomez R, Garcia-Sevila R, Garde J, Gasco A, Gil J, Gonzalez-Larriba JL, Hernando-Polo S, Jantus E, Insa A, Isla D, Jimenez B, Lianes P, Lopez-Lopez R, Lopez-Martin A, Lopez-Vivanco G, Macias JA, Majem M, Marti-Ciriquian JL, Massuti B, Montoyo R, Morales-Espinosa D, Moran T, Moreno MA, Pallares C, Parera M, Perez-Carrion R, Porta R, Provencio M, Reguart N, Rosell R, Rosillo F, Sala MA, Sanchez JM, Sullivan I, Terrasa J, Trigo JM, Valdivia J, Vinolas N, Viteri S, Botia-Castillo M, Mate JL, Perez-Cano M, Ramirez JL, Sanchez-Rodriguez B, Taron M, Tierno-Garcia M, Mijangos E, Ocana J, Pereira E, Shao J, Sun X, O'Brate R. Two biomarker-directed randomized trials in European and Chinese patients with nonsmall-cell lung cancer: the BRCA1-RAP80 Expression Customization (BREC) studies. Ann Oncol. 2014 Nov;25(11):2147-2155. doi: 10.1093/annonc/mdu389. Epub 2014 Aug 27.

  PMID: 25164908 DERIVED

Related Links

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

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Interventions

Cisplatin; Docetaxel; Gemcitabine

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Limitations and Caveats

The were a early closure of the study and it was notified to comply with the regulations for early termination of the studies. clinical trials (futility analysis).

Results Point of Contact

• Title: Eva Pereira
• Organization: Fundación GECP

gecp@gecp.org

+34 934302006

Study Officials

• Rafel Rossell, MD

  Principal Investigator of Fundación Grupo Español de Cáncer de Pulmón

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2008
• First Posted: February 18, 2008
• Study Start: February 1, 2008
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: January 30, 2024
• Results First Posted: January 30, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (44)