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

This study has suspended participant recruitment.
(the DSMB stopped the trial due to unacceptable side effects in the experimental arm which has not yet been verified)
Sponsor:
Collaborator:
Gesellschaft fur Medizinische Innovation – Hamatologie und Onkologie mbH
Information provided by (Responsible Party):
WiSP Wissenschaftlicher Service Pharma GmbH
ClinicalTrials.gov Identifier:
NCT01088620
First received: March 16, 2010
Last updated: March 13, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention Phase
Carcinoma, Non-Small-Cell Lung
Drug: Panitumumab
Drug: Pemetrexed
Drug: Cisplatin
Phase 2

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

Resource links provided by NLM:


Further study details as provided by WiSP Wissenschaftlicher Service Pharma GmbH:

Primary Outcome Measures:
  • Progression free survival rate at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Determination of the tumour response [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: 6 month ] [ Designated as safety issue: No ]
  • Adverse effects / toxicity [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Quality of life assessment [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 134
Study Start Date: April 2010
Estimated Study Completion Date: January 2014
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Panitumumab plus pemetrexed and cisplatin (PemCisP) 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.

Other Name: Vectibix
Drug: Pemetrexed
Pemetrexed 500 mg/m² will be administered IV every 3 weeks (q3w) for a maximum of four cycles.
Other Name: Alimta
Drug: Cisplatin
Cisplatin 75 mg/m² will be administered IV every 3 weeks (q3w) for a maximum of four cycles.
Active Comparator: Pemetrexed and cisplatin (PemCis) Drug: Pemetrexed
Pemetrexed 500 mg/m² will be administered IV every 3 weeks (q3w) for a maximum of four cycles.
Other Name: Alimta
Drug: Cisplatin
Cisplatin 75 mg/m² will be administered IV every 3 weeks (q3w) for a maximum of four cycles.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01088620

Locations
Germany
Schwerpunktpraxis für Hämatologie und Internistische Onkologie, Gesundheitszentrum St. Marien GmbH
Amberg, Germany, 92224
HELIOS Klinikum Emil von Behring - Lungenklinik Heckeshorn
Berlin, Germany, 14165
Universitätsklinikum Charité - Campus Mitte
Berlin, Germany, 10117
Charité Campus Benjamin Franklin Medizinische Klinik m. S. Hämatologie und Onkologie
Berlin, Germany, 12200
Augusta-Kranken-Anstalt gGmbH
Bochum, Germany, 44791
Johanniter-Krankenhaus Bonn
Bonn, Germany, 53113
Carl-Thiem-Klinikum Cottbus gGmbH
Cottbus, Germany, 03048
Medizinische Fakultät Carl Gustav Carus der Technischen Universität Dresden Medizinische Klinik 1
Dresden, Germany, 01307
Katholisches Klinikum Duisburg/St. Johannes-Hospital
Duisburg, Germany, 47166
Klinikum Frankfurt (Oder) GmbH
Frankfurt (Oder), Germany, 15236
Krankenhaus Großhansdorf GmbH Onkologischer Schwerpunkt
Großhansdorf, Germany, 22927
Universitätsklinikum Halle (Saale), Klinik und Poliklinik für Innere Medizin I
Halle/Saale, Germany, 06120
Krankenhaus - Martha-Maria Halle-Dölau GmbH
Halle/Saale, Germany, 06120
Universitätsklinikum Jena, Klinik für Innere Medizin I
Jena, Germany, 07740
Onkologische Schwerpunktpraxis Dr. Stauch
Kronach, Germany, 96317
Kliniken der Stadt Köln, Krankenhaus Merheim
Köln, Germany, 51109
UK-SH, Campus Lübeck, Med. Klinik III
Lübeck, Germany, 23538
LMU-Klinikum der Universität München, Medizinische Klinik München-Innenstadt
München, Germany, 80336
Oncologianova GmbH
Recklinghausen, Germany, 45657
Uniklinikum Ulm, Klinik für Innere Medizin II, Pneumologie
Ulm, Germany, 89081
Sponsors and Collaborators
WiSP Wissenschaftlicher Service Pharma GmbH
Gesellschaft fur Medizinische Innovation – Hamatologie und Onkologie mbH
Investigators
Principal Investigator: Wolfgang Schütte, MD Krankenhaus Martha-Maria Halle-Dölau
  More Information

No publications provided

Responsible Party: WiSP Wissenschaftlicher Service Pharma GmbH
ClinicalTrials.gov Identifier: NCT01088620     History of Changes
Other Study ID Numbers: WISP_AG47, 2009-014677-41, GMIHO-006/2008
Study First Received: March 16, 2010
Last Updated: March 13, 2013
Health Authority: Germany: Paul-Ehrlich-Institut

Keywords provided by WiSP Wissenschaftlicher Service Pharma GmbH:
NSCLC
Stage IIIb or IV
Nonsquamous
KRAS-Wildtype

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Pemetrexed
Cisplatin
Antibodies, Monoclonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Folic Acid Antagonists
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 26, 2014