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Carcinoma, Non-Small-Cell LungPhase 2NCT01088620

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

A Phase 2 study testing Panitumumab, Pemetrexed and Cisplatin in people with Carcinoma, Non-Small-Cell Lung, run by WiSP Wissenschaftlicher Service Pharma GmbH at 20 sites in Germany.

Suspended

Paused. Enrolment is on hold for now and may resume.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carcinoma, Non-Small-Cell Lung
What is being tested?
Panitumumab, Pemetrexed and Cisplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
134 participants
Where
20 sitesGermany
Study dates
Apr 2010to Jan 2014
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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).
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  • 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

Trial locations and contacts

20 sites in 1 country.

20 sites in 1 country

Germany20 sites

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

    Amberg, 92224

  • Universitätsklinikum Charité - Campus Mitte

    Berlin, 10117

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

    Berlin, 12200

  • HELIOS Klinikum Emil von Behring - Lungenklinik Heckeshorn

    Berlin, 14165

  • Augusta-Kranken-Anstalt gGmbH

    Bochum, 44791

  • Johanniter-Krankenhaus Bonn

    Bonn, 53113

  • Kliniken der Stadt Köln, Krankenhaus Merheim

    Cologne, 51109

  • Carl-Thiem-Klinikum Cottbus gGmbH

    Cottbus, 03048

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

    Dresden, 01307

  • Katholisches Klinikum Duisburg/St. Johannes-Hospital

    Duisburg, 47166

  • Klinikum Frankfurt (Oder) GmbH

    Frankfurt (Oder), 15236

  • Krankenhaus Großhansdorf GmbH Onkologischer Schwerpunkt

    Großhansdorf, 22927

  • Krankenhaus - Martha-Maria Halle-Dölau GmbH

    Halle, 06120

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

    Halle, 06120

  • Universitätsklinikum Jena, Klinik für Innere Medizin I

    Jena, 07740

  • Onkologische Schwerpunktpraxis Dr. Stauch

    Kronach, 96317

  • UK-SH, Campus Lübeck, Med. Klinik III

    Lübeck, 23538

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

    München, 80336

  • Oncologianova GmbH

    Recklinghausen, 45657

  • Uniklinikum Ulm, Klinik für Innere Medizin II, Pneumologie

    Ulm, 89081

Other trials in Germany

About this study

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

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.

Being tested
Panitumumab, Pemetrexed, Cisplatin
Keywords
NSCLC, Stage IIIb or IV, Nonsquamous, KRAS-Wildtype
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PanitumumabDrug

    Also called Vectibix

    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.

  • PemetrexedDrug

    Also called Alimta

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

  • CisplatinDrug

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

Study groups in NCT01088620
Study groupRoleWhat they receive
Panitumumab plus pemetrexed and cisplatin (PemCisP)ExperimentalNot described
Receives: Drug: Panitumumab; Drug: Pemetrexed; Drug: Cisplatin
Pemetrexed and cisplatin (PemCis)Active comparatorNot described
Receives: Drug: Pemetrexed; Drug: Cisplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression free survival rate at 6 months

    Measured: 6 months

Secondary outcomes (5)

  1. Determination of the tumour response

    Measured: 6 months

  2. Duration of response

    Measured: 6 months

  3. Overall survival

    Measured: 6 month

  4. Adverse effects / toxicity

    Measured: 6 months

  5. Quality of life assessment

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Mar 2010 (estimated)
  2. Study startApr 2010
  3. Primary completionJan 2013
  4. Study completionJan 2014 (estimated)

Why it stopped: the DSMB stopped the trial due to unacceptable side effects in the experimental arm which has not yet been verified

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
134 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01088620
Sponsor's protocol ID
WISP_AG47
Other IDs
2009-014677-41, GMIHO-006/2008, 2009
Status last verified
Mar 2013
First submitted
16 Mar 2010
Last updated
14 Mar 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 26094080

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Panitumumab, Pemetrexed and Cisplatin in people with Carcinoma, Non-Small-Cell Lung, run by WiSP Wissenschaftlicher Service Pharma GmbH at 20 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: paused, as of the sponsor's last update on 14 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression free survival rate at 6 months (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01088620, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2013.

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