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

WiSP Wissenschaftlicher Service Pharma

Status and phase

Suspended

Phase 2

Conditions

Carcinoma, Non-Small-Cell Lung

Treatments

Drug: Cisplatin

Drug: Pemetrexed

Drug: Panitumumab

Study type

Interventional

Funder types

Other

Identifiers

NCT01088620

2009-014677-41 (EudraCT Number)

WISP_AG47

GMIHO-006/2008 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

134 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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