Panitumumab Plus Pemetrexed and Cisplatin (PemCisP) Versus PemCis in the First-line Treatment of Patients With Non-small Cell Lung Cancer

NCT ID: NCT01088620

Last Updated: 2013-03-14

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: PHASE2
• Total Enrollment: 134 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-04-30
• Study Completion Date: 2014-01-31

Brief Summary

The purpose of this trial is to estimate the therapeutic efficacy of the experimental targeted regimen including the EGFR antibody panitumumab (in combination with pemetrexed and cisplatin) in relation to the standard combination in patients with a KRAS wild-type stage IIIB or IV primary nonsquamous non-small cell lung cancer. It is expected that the progression free survival rate at 6 months is improved by the targeted regimen.

Conditions

Carcinoma, Non-Small-Cell Lung

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Panitumumab plus pemetrexed and cisplatin (PemCisP)

Group Type: EXPERIMENTAL

Panitumumab

Intervention Type: DRUG

Panitumumab 9 mg/kg BW will be administered IV every 3 weeks (q3w) for a maximum of four cycles.

In case of CR, PR or SD status at the end of the combination treatment, a panitumumab single drug treatment, consisting of 9 mg/kg BW administered every 3 weeks, will be performed until detection of disease progression.

Pemetrexed

Intervention Type: DRUG

Pemetrexed 500 mg/m² will be administered IV every 3 weeks (q3w) for a maximum of four cycles.

Cisplatin

Intervention Type: DRUG

Cisplatin 75 mg/m² will be administered IV every 3 weeks (q3w) for a maximum of four cycles.

Pemetrexed and cisplatin (PemCis)

Group Type: ACTIVE_COMPARATOR

Pemetrexed

Intervention Type: DRUG

Pemetrexed 500 mg/m² will be administered IV every 3 weeks (q3w) for a maximum of four cycles.

Cisplatin

Intervention Type: DRUG

Cisplatin 75 mg/m² will be administered IV every 3 weeks (q3w) for a maximum of four cycles.

Interventions

Panitumumab

Panitumumab 9 mg/kg BW will be administered IV every 3 weeks (q3w) for a maximum of four cycles.

In case of CR, PR or SD status at the end of the combination treatment, a panitumumab single drug treatment, consisting of 9 mg/kg BW administered every 3 weeks, will be performed until detection of disease progression.

Intervention Type: DRUG

Pemetrexed

Pemetrexed 500 mg/m² will be administered IV every 3 weeks (q3w) for a maximum of four cycles.

Intervention Type: DRUG

Cisplatin

Cisplatin 75 mg/m² will be administered IV every 3 weeks (q3w) for a maximum of four cycles.

Intervention Type: DRUG

Other Intervention Names

Vectibix; Alimta

Eligibility Criteria

Inclusion Criteria

• Histologically confirmed diagnosis of inoperable stage IIIB or IV primary pulmonary nonsquamous NSCLC (according to UICC staging valid until 2008)
• Sufficient representative sample material for KRAS analysis
• Wild-type KRAS
• Informed consent of the patient
• Aged at least 18 years
• WHO Performance Status 0-2
• At least one unidimensional, measurable tumour parameter according to RECIST
• Life expectancy of al least 12 weeks
• Adequate haematological, hepatic, renal and metabolic function parameters:

• Leukocytes > 3000/mm³, ANC ≥ 1500/mm3, platelets ≥ 100,000/mm3, Creatinine clearance ≥ 50 ml/min and serum creatinine ≤ 1.5 x upper limit of normal
• Bilirubin ≤ 1.5 x upper limit of normal, GOT-GPT ≤ 2.5 x upper limit of normal in absence of liver metastases, or ≤ 5 x upper limit of normal in presence of liver metastases, AP ≤ 5 x upper limit of normal
• Magnesium ≥ lower limit of normal; calcium ≥ lower limit of normal

Exclusion Criteria

• Prior chemotherapy
• Clinically manifest, uncontrolled brain metastases
• Prior radiotherapy of the parameters to be measured
• Peripheral neuropathy NCI grade > 1
• Subject pregnant or breast feeding, or planning to become pregnant within 6 months after the end of treatment.
• Subject (male or female) is not willing to use highly effective methods of contraception (per institutional standard) during treatment and for 6 months (male or female) after the end of treatment (adequate: oral contraceptives, intrauterine device or barrier method in conjunction with spermicidal jelly).
• Serious concurrent diseases.
• Major surgery within the last 4 weeks before recruitment
• On-treatment participation in a clinical study in the period 30 days prior to inclusion.
• Clinically significant cardiovascular disease in (incl. myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) ≤ 1 year before enrolment.
• Ongoing or active infection, including active tuberculosis or known infection with human immunodeficiency virus.
• Superior vena cava syndrome contraindicating hydration.
• History of interstitial lung disease, e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan.
• Patient with mild to moderate renal insufficiency who are unable to interrupt salicylates (like aspirin) or other nonsteroidal anti-inflammatory drugs (NSAIDS) for a 5-day period starting 2 days before administration of pemetrexed (8-day period for long-acting agents such as piroxicam). Exception: Low dose aspirin (acetyl salicylic acid) intake up to 150 mg per day is permitted without interruption.
• Presence of clinically significant third-space fluid collections, for example, ascites or pleural effusions that cannot be controlled by drainage or other procedures
• Inability or unwillingness to take folic acid, vitamin B12 supplementation or dexamethasone (or equivalent corticosteroid); or any other inability to comply with protocol or study related procedures
• Prior or concurrent malignancy (≤ 5 years prior to enrolment in study) except non-melanoma skin cancer or cervical carcinoma FIGO stage 0-1 if the patient is continuously disease-free
• Known allergic reactions on study medication

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH

OTHER

Sponsor Role: collaborator

WiSP Wissenschaftlicher Service Pharma GmbH

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wolfgang Schütte, MD

Role: PRINCIPAL_INVESTIGATOR

Krankenhaus Martha-Maria Halle-Dölau

Locations

Schwerpunktpraxis für Hämatologie und Internistische Onkologie, Gesundheitszentrum St. Marien GmbH

Amberg, , Germany

Universitätsklinikum Charité - Campus Mitte

Berlin, , Germany

Charité Campus Benjamin Franklin Medizinische Klinik m. S. Hämatologie und Onkologie

Berlin, , Germany

HELIOS Klinikum Emil von Behring - Lungenklinik Heckeshorn

Berlin, , Germany

Augusta-Kranken-Anstalt gGmbH

Bochum, , Germany

Johanniter-Krankenhaus Bonn

Bonn, , Germany

Kliniken der Stadt Köln, Krankenhaus Merheim

Cologne, , Germany

Carl-Thiem-Klinikum Cottbus gGmbH

Cottbus, , Germany

Medizinische Fakultät Carl Gustav Carus der Technischen Universität Dresden Medizinische Klinik 1

Dresden, , Germany

Katholisches Klinikum Duisburg/St. Johannes-Hospital

Duisburg, , Germany

Klinikum Frankfurt (Oder) GmbH

Frankfurt (Oder), , Germany

Krankenhaus Großhansdorf GmbH Onkologischer Schwerpunkt

Großhansdorf, , Germany

Krankenhaus - Martha-Maria Halle-Dölau GmbH

Halle, , Germany

Universitätsklinikum Halle (Saale), Klinik und Poliklinik für Innere Medizin I

Halle, , Germany

Universitätsklinikum Jena, Klinik für Innere Medizin I

Jena, , Germany

Onkologische Schwerpunktpraxis Dr. Stauch

Kronach, , Germany

UK-SH, Campus Lübeck, Med. Klinik III

Lübeck, , Germany

LMU-Klinikum der Universität München, Medizinische Klinik München-Innenstadt

München, , Germany

Oncologianova GmbH

Recklinghausen, , Germany

Uniklinikum Ulm, Klinik für Innere Medizin II, Pneumologie

Ulm, , Germany

Countries

Germany

References

Schuette W, Behringer D, Stoehlmacher J, Kollmeier J, Schmager S, Fischer von Weikersthal L, Schumann C, Buchmann J. CHAMP: A Phase II Study of Panitumumab With Pemetrexed and Cisplatin Versus Pemetrexed and Cisplatin in the Treatment of Patients With Advanced-Stage Primary Nonsquamous Non-Small-Cell Lung Cancer With Particular Regard to the KRAS Status. Clin Lung Cancer. 2015 Nov;16(6):447-56. doi: 10.1016/j.cllc.2015.05.009. Epub 2015 Jun 2.

Reference Type: DERIVED

PMID: 26094080 (View on PubMed)

Other Identifiers

2009-014677-41

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

GMIHO-006/2008

Identifier Type: OTHER

Identifier Source: secondary_id

WISP_AG47

Identifier Type: -

Identifier Source: org_study_id