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

Carcinoma, Non-Small-Cell Lung Clinical Trial

Official title:

CHAMP - An Open-label, Randomised, Multicentre, Phase II Clinical Study of Panitumumab Plus Pemetrexed and Cisplatin (PemCisP) Versus PemCis in the First-line Treatment of Patients With Stage IIIB or IV Primary Nonsquamous Non-small Cell Lung Cancer, With Particular Regard to the KRAS Status

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT01088620
• Other study ID #: WISP_AG47
• Secondary ID: 2009-014677-41GM
• Status: Suspended
• Phase: Phase 2
• First received: March 16, 2010
• Last updated: March 13, 2013
• Start date: April 2010
• Est. completion date: January 2014

Study information

• Verified date: March 2013
• Source: WiSP Wissenschaftlicher Service Pharma GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Paul-Ehrlich-Institut
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 134
• Est. completion date: January 2014
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung

Intervention

Drug:
• 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.
• Pemetrexed
Pemetrexed 500 mg/m² will be administered IV every 3 weeks (q3w) for a maximum of four cycles.
• Cisplatin
Cisplatin 75 mg/m² will be administered IV every 3 weeks (q3w) for a maximum of four cycles.

Locations

Country	Name	City	State
Germany	Schwerpunktpraxis für Hämatologie und Internistische Onkologie, Gesundheitszentrum St. Marien GmbH	Amberg
Germany	Charité Campus Benjamin Franklin Medizinische Klinik m. S. Hämatologie und Onkologie	Berlin
Germany	HELIOS Klinikum Emil von Behring - Lungenklinik Heckeshorn	Berlin
Germany	Universitätsklinikum Charité - Campus Mitte	Berlin
Germany	Augusta-Kranken-Anstalt gGmbH	Bochum
Germany	Johanniter-Krankenhaus Bonn	Bonn
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/Saale
Germany	Universitätsklinikum Halle (Saale), Klinik und Poliklinik für Innere Medizin I	Halle/Saale
Germany	Universitätsklinikum Jena, Klinik für Innere Medizin I	Jena
Germany	Kliniken der Stadt Köln, Krankenhaus Merheim	Köln
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

Sponsors (2)

Lead Sponsor	Collaborator
WiSP Wissenschaftlicher Service Pharma GmbH	Gesellschaft fur Medizinische Innovation – Hamatologie und Onkologie mbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival rate at 6 months		6 months	No
Secondary	Determination of the tumour response		6 months	No
Secondary	Duration of response		6 months	No
Secondary	Overall survival		6 month	No
Secondary	Adverse effects / toxicity		6 months	Yes
Secondary	Quality of life assessment		6 months	No