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

NCT01088620 | Suspended Phase 2 DMC

• 3 other identifiers: WISP_AG472009-014677-41GMIHO-006/2008
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 20

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

Keywords

NSCLC; Stage IIIb or IV; Nonsquamous; KRAS-Wildtype

Outcome Measures

Primary Outcomes (1)

• Progression free survival rate at 6 months

  6 months

Secondary Outcomes (5)

• Determination of the tumour response

  6 months

• Duration of response

  6 months

• Overall survival

  6 month

• Adverse effects / toxicity

  6 months

• Quality of life assessment

  6 months

Study Arms (2)

Panitumumab plus pemetrexed and cisplatin (PemCisP)

EXPERIMENTAL

Drug: Panitumumab; Drug: Pemetrexed; Drug: Cisplatin

Pemetrexed and cisplatin (PemCis)

ACTIVE COMPARATOR

Drug: Pemetrexed; Drug: Cisplatin

Interventions

Panitumumab 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.

Also known as: Vectibix

Panitumumab plus pemetrexed and cisplatin (PemCisP)

Pemetrexed DRUG

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

Also known as: Alimta

Panitumumab plus pemetrexed and cisplatin (PemCisP); Pemetrexed and cisplatin (PemCis)

Cisplatin DRUG

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

Panitumumab plus pemetrexed and cisplatin (PemCisP); Pemetrexed and cisplatin (PemCis)

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• WiSP Wissenschaftlicher Service Pharma GmbH: lead
• Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH: collaborator

Study Sites (20)

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

Amberg, 92224, Germany

Location

Universitätsklinikum Charité - Campus Mitte

Berlin, 10117, Germany

Location

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

Berlin, 12200, Germany

Location

HELIOS Klinikum Emil von Behring - Lungenklinik Heckeshorn

Berlin, 14165, Germany

Location

Augusta-Kranken-Anstalt gGmbH

Bochum, 44791, Germany

Location

Johanniter-Krankenhaus Bonn

Bonn, 53113, Germany

Location

Kliniken der Stadt Köln, Krankenhaus Merheim

Cologne, 51109, Germany

Location

Carl-Thiem-Klinikum Cottbus gGmbH

Cottbus, 03048, Germany

Location

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

Dresden, 01307, Germany

Location

Katholisches Klinikum Duisburg/St. Johannes-Hospital

Duisburg, 47166, Germany

Location

Klinikum Frankfurt (Oder) GmbH

Frankfurt (Oder), 15236, Germany

Location

Krankenhaus Großhansdorf GmbH Onkologischer Schwerpunkt

Großhansdorf, 22927, Germany

Location

Krankenhaus - Martha-Maria Halle-Dölau GmbH

Halle, 06120, Germany

Location

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

Halle, 06120, Germany

Location

Universitätsklinikum Jena, Klinik für Innere Medizin I

Jena, 07740, Germany

Location

Onkologische Schwerpunktpraxis Dr. Stauch

Kronach, 96317, Germany

Location

UK-SH, Campus Lübeck, Med. Klinik III

Lübeck, 23538, Germany

Location

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

München, 80336, Germany

Location

Oncologianova GmbH

Recklinghausen, 45657, Germany

Location

Uniklinikum Ulm, Klinik für Innere Medizin II, Pneumologie

Ulm, 89081, Germany

Location

Related Publications (1)

• 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.

  PMID: 26094080 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Panitumumab; Pemetrexed; Cisplatin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Dicarboxylic; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Wolfgang Schütte, MD

  Krankenhaus Martha-Maria Halle-Dölau

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2010
• First Posted: March 17, 2010
• Study Start: April 1, 2010
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2014
• Last Updated: March 14, 2013

Record last verified: 2013-03

Locations

DE (20)