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Efficacy and Safety of Cetuximab in Combination With Cisplatin Gemcitabine as First-Line Therapy in Advanced NSCLC (Coimbra)

Primary Purpose

Carcinoma, Non-Small-Cell Lung

Status

Unknown status

Phase

Phase 2

Locations

Portugal

Study Type

Interventional

Intervention

CETUXIMAB

About this trial

This is an interventional treatment trial for Carcinoma, Non-Small-Cell Lung focused on measuring Coimbra, NSCLC, CETUXIMAB

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Signed written informed consent
Male or female ≥18 years of age
Cito-histological diagnosis of NSCLC, stage IV
Performance Status = 0 or 1
Measurable disease on CT scan - RECIST criteria
White blood count ≥ 3 x 109/L, Neutrophils ≥ 1.5 x 109/L,
platelets ≥ 100 x 109/L, and hemoglobin ≥ 9 g/dL
Bilirubin level either normal or ≤1.5 x ULN
ASAT and ALAT ≤ 2.5 x ULN (or 5 x ULN in case of liver metastases)
Alkaline phosphatase ≤ 2,5 x ULN or ≤ 5 x ULN in case of bone metastases
Creatinine clearance ≥ 50 ml/min
Negative pregnancy test within one week before treatment start, if applicable
Life expectancy of ≥ 3 months
Availability of tumor sample (or able and willing to provide tumor sample) for EGFR assessment
Effective contraception for both male and female patients if the risk of conception exists

Exclusion Criteria:

Documented or symptomatic brain metastases
Previous chemotherapy for NSCLC including adjuvant chemotherapy
Concurrent chronic systemic immune therapy, chemotherapy, or hormone therapy not indicated in the study protocol
Any investigational agent(s) within 4 weeks prior to entry
Major surgery within 4 weeks prior to study entry
Prior chest irradiation within 12 weeks prior to study entry (palliative radiation of bone lesions is allowed)
Superior vena cava syndrome contra-indicating hydratation
Previous exposure to EGF, monoclonal antibodies, signal transduction inhibitors or EGFR targeting therapy
Myocardial infraction within 6 months prior to study entry, uncontrolled congestive heart failure; or any current grade 3 or 4 cardio-vascular disorder despite treatment
Known allergic / hypersensitivity reaction to any of the components of study treatments
Known drug abuse/ alcohol abuse
Legal incapacity or limited legal capacity
Symptomatic peripheral neuropathy (NCI-CTC) ≥ 2 and/or ototoxicity grade ≥ 2 , except if due to trauma or mechanical impairment due to tumor mass
Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent
Pregnancy or breastfeeding
Any previous or concurrent malignancy other than nonmelanoma skin cancer, or carcinoma in situ of the cervix. (Patients with a previous malignancy but without evidence of disease for > 5 years will be allowed to enter the trial)

Sites / Locations

fERNANDO bARATARecruiting

Arms of the Study

Arm 1

Arm Type

No Intervention

Arm Label

Arm Description

CISPLATIN gENCITABINE cETUXIMAB

Outcomes

Primary Outcome Measures

oVERALL RESPONSE RATE

Secondary Outcome Measures

tIME TO PROGRESSION oVERALL SORVIVAL SAFETY

Full Information

NCT ID

NCT00561054

First Posted

November 19, 2007

Last Updated

November 19, 2007

Sponsor

Grupo Portugues de Estudo do Cancro do Pulmao

1. Study Identification

Unique Protocol Identification Number

NCT00561054

Brief Title

Efficacy and Safety of Cetuximab in Combination With Cisplatin Gemcitabine as First-Line Therapy in Advanced NSCLC

Acronym

Coimbra

Official Title

Open-Label, Uncontrolled, Multicenter, Phase II Study Evaluating the Efficacy and Safety of Cetuximab in Combination With Cisplatin & Gemcitabine as First-Line Therapy in Patients With Advanced Non Small Cell Lung Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

November 2007

Overall Recruitment Status

Unknown status

Study Start Date

March 2007 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Grupo Portugues de Estudo do Cancro do Pulmao

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Lung cancer is the leading cause of cancer deaths worldwide. It is estimated that, in 2004, 173,700 new cases of lung cancer will be diagnosed in the United States alone and 164,440 deaths due to this disease will occur(13) . NSCLC accounts for approximately 80% of all lung cancers. Among NSCLC cases approximately 30% present with locally advanced and 40% with metastatic disease (14,15) . In metastatic disease, chemotherapy is the treatment of choice, but benefits obtained in survival have been modest. Five-year survival is less than 15%, probably due to diagnosis at late stages. Surgical results in earlier stages are poor compared to other tumor types (about 40% of recurrence in stages I-II). Results of chemotherapy in advanced stages are also poor (one-year survival of 40%) (15,17). It is commonly accepted that the standard treatment for advanced disease (stage IV and IIIb with malignant pleural effusion) consists of platinum-based chemotherapy(15,16) . However, there are many open questions in the management of these patients, such as the role of 3-drugs combinations, non-platinum-based therapies, and new biologic therapeutics' approaches. Currently, in the treatment of advanced NSCLC response rates of about 20%-30% and median survival times of 6 to 11 months have been achieved (16, 17, 18, 19, 20, 21, 22,). Several combinations of drugs are used and show similar efficacy. Cisplatin plus vinorelbine or Cisplatin plus Gemcitabine are among the most commonly used regimens in the first-line therapy of NSCLC.

Detailed Description

Criteria for inclusion Signed written informed consent Male or female ≥18 years of age Cito-histological diagnosis of NSCLC, stage IV Performance Status = 0 or 1 Measurable disease on CT scan - RECIST criteria White blood count ≥ 3 x 109/L, Neutrophils ≥ 1.5 x 109/L, platelets ≥ 100 x 109/L, and hemoglobin ≥ 9 g/dL Bilirubin level either normal or ≤1.5 x ULN ASAT and ALAT ≤ 2.5 x ULN (or 5 x ULN in case of liver metastases) Alkaline phosphatase ≤ 2,5 x ULN or ≤ 5 x ULN in case of bone metastases Creatinine clearance ≥ 50 ml/min Negative pregnancy test within one week before treatment start, if applicable Life expectancy of ≥ 3 months Availability of tumor sample (or able and willing to provide tumor sample) for EGFR assessment Effective contraception for both male and female patients if the risk of conception exists Criteria for exclusion Documented or symptomatic brain metastases Previous chemotherapy for NSCLC including adjuvant chemotherapy Concurrent chronic systemic immune therapy, chemotherapy, or hormone therapy not indicated in the study protocol Any investigational agent(s) within 4 weeks prior to entry Major surgery within 4 weeks prior to study entry Prior chest irradiation within 12 weeks prior to study entry (palliative radiation of bone lesions is allowed) Superior vena cava syndrome contra-indicating hydratation Previous exposure to EGF, monoclonal antibodies, signal transduction inhibitors or EGFR targeting therapy Myocardial infraction within 6 months prior to study entry, uncontrolled congestive heart failure; or any current grade 3 or 4 cardio-vascular disorder despite treatment Known allergic / hypersensitivity reaction to any of the components of study treatments Known drug abuse/ alcohol abuse Legal incapacity or limited legal capacity Symptomatic peripheral neuropathy (NCI-CTC) ≥ 2 and/or ototoxicity grade ≥ 2 , except if due to trauma or mechanical impairment due to tumor mass Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent Pregnancy or breastfeeding Any previous or concurrent malignancy other than nonmelanoma skin cancer, or carcinoma in situ of the cervix. (Patients with a previous malignancy but without evidence of disease for > 5 years will be allowed to enter the trial)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Carcinoma, Non-Small-Cell Lung

Keywords

Coimbra, NSCLC, CETUXIMAB

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

47 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

No Intervention

Arm Description

CISPLATIN gENCITABINE cETUXIMAB

Intervention Type

Drug

Intervention Name(s)

CETUXIMAB

Intervention Description

400 mg/m2 starting dose, 250 mg/m2 weekly dose

Primary Outcome Measure Information:

Title

oVERALL RESPONSE RATE

Time Frame

30/11/2009

Secondary Outcome Measure Information:

Title

tIME TO PROGRESSION oVERALL SORVIVAL SAFETY

Time Frame

30/11/2009

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Signed written informed consent Male or female ≥18 years of age Cito-histological diagnosis of NSCLC, stage IV Performance Status = 0 or 1 Measurable disease on CT scan - RECIST criteria White blood count ≥ 3 x 109/L, Neutrophils ≥ 1.5 x 109/L, platelets ≥ 100 x 109/L, and hemoglobin ≥ 9 g/dL Bilirubin level either normal or ≤1.5 x ULN ASAT and ALAT ≤ 2.5 x ULN (or 5 x ULN in case of liver metastases) Alkaline phosphatase ≤ 2,5 x ULN or ≤ 5 x ULN in case of bone metastases Creatinine clearance ≥ 50 ml/min Negative pregnancy test within one week before treatment start, if applicable Life expectancy of ≥ 3 months Availability of tumor sample (or able and willing to provide tumor sample) for EGFR assessment Effective contraception for both male and female patients if the risk of conception exists Exclusion Criteria: Documented or symptomatic brain metastases Previous chemotherapy for NSCLC including adjuvant chemotherapy Concurrent chronic systemic immune therapy, chemotherapy, or hormone therapy not indicated in the study protocol Any investigational agent(s) within 4 weeks prior to entry Major surgery within 4 weeks prior to study entry Prior chest irradiation within 12 weeks prior to study entry (palliative radiation of bone lesions is allowed) Superior vena cava syndrome contra-indicating hydratation Previous exposure to EGF, monoclonal antibodies, signal transduction inhibitors or EGFR targeting therapy Myocardial infraction within 6 months prior to study entry, uncontrolled congestive heart failure; or any current grade 3 or 4 cardio-vascular disorder despite treatment Known allergic / hypersensitivity reaction to any of the components of study treatments Known drug abuse/ alcohol abuse Legal incapacity or limited legal capacity Symptomatic peripheral neuropathy (NCI-CTC) ≥ 2 and/or ototoxicity grade ≥ 2 , except if due to trauma or mechanical impairment due to tumor mass Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent Pregnancy or breastfeeding Any previous or concurrent malignancy other than nonmelanoma skin cancer, or carcinoma in situ of the cervix. (Patients with a previous malignancy but without evidence of disease for > 5 years will be allowed to enter the trial)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Fernando Barata, MD

Phone

00351239 800 195

fjssbarata@sapo.pt

First Name & Middle Initial & Last Name or Official Title & Degree

Agostinho Costa, MD

Phone

00351 21 7548032

costa.agostinho@clix.pt

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Fernando Barata, MD

Organizational Affiliation

Grupo Portugues de Estudo do Cancro do Pulmao

Official's Role

Principal Investigator

Facility Information:

Facility Name

fERNANDO bARATA

City

cOIMBRA

ZIP/Postal Code

3040

Country

Portugal

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Fernando Barata, MD

Phone

00351 239 800 195

fjssbarata@sapo.pt

First Name & Middle Initial & Last Name & Degree

Agostinho Costa, MD

Phone

00351 21 7548032

COSTA.AGOSTINHO@CLIX.PT

12. IPD Sharing Statement

Learn more about this trial

Efficacy and Safety of Cetuximab in Combination With Cisplatin Gemcitabine as First-Line Therapy in Advanced NSCLC

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