Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/NCT01038037
NCT01038037TerminatedPhase 2

A Phase II Study of First-Line Chemotherapy and Panitumumab in Advanced NSCLC Selected by Mutational Status

Vejle Hospital1 site in 1 country23 target enrollmentStarted: January 1, 2010Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Terminated
Enrollment
23
Locations
1
Primary Endpoint
Response rate
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

The purpose of this study is to determine whether the addition of panitumumab to standard chemotherapy in first-line treatment of advanced Non Small Cell Lung Cancer improves the treatment outcome. Patients are selected based on triple mutational status.

Detailed Description

Advanced NSCLC holds a very poor prognosis with a moderate response rate to standard chemotherapy. The standard first-line treatment for advanced NSCLC is platinum based combination chemotherapy. The response rates are less than 30% and a substantial amount of patients will experience unnecessary toxicity in terms of e.g. nausea, vomiting, neuropathies or a considerable risk of renal toxicity. The median progression free survival is 3-4 months and consequently, the median overall survival is less than one year (Hotta et al 2007). Addition of new biological agents to standard chemotherapy regimens may improve the outcome for these patients.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Factorial
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Histologically confirmed metastatic (stage IV) NSCLC
  • •Measurable disease according to RECIST v.1.0 2009
  • •KRAS, BRAF and PI3K wild type in primary tumor or metastatic tissue.
  • •Adequate organ function
  • •Haematology:
  • •Neutrophil count ≥1.5x10^9/L
  • •Platelet count ≥100x10^9/L
  • •Leucocyte count > 3,000/mm
  • •Hepatic function:
  • •Total bilirubin ≤ 1.5 times the upper normal limit (UNL)
  • •Serum transaminases ≤ 2.5xUNL in absence of liver metastases, or ≤ 5xUNL in presence of liver metastases
  • •Renal Function:
  • •Creatinine clearance ≥ 50 mL/min and serum creatinine ≤ 1.5xUNL
  • •Metabolic function:
  • •Magnesium ≥ lower limit of normal.
  • •Calcium ≥ lower limit of normal.
  • •Consent to translational research studies
  • •Written informed consent

Exclusion Criteria

  • •Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) ≤ 1 year before enrollment/randomization, active severe infections or other concurrent disease.
  • •Known CNS metastasis (pretreatment routine assessment not required)
  • •Prior chemotherapy for metastatic disease
  • •Indication for radiation therapy or prior radiotherapy within 30 days before treatment start.
  • •Other malignant diseases within 5 years prior to inclusion in the study, except basal cell squamous carcinoma of the skin and cervical carcinoma-in-situ.
  • •Other experimental therapy within 30 days prior to treatment initiation.
  • •History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan.
  • •Patients pregnant or breast feeding, or planning to become pregnant within 6 months after the end of treatment.
  • •Patients (male or female) 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.

Outcomes

Primary Outcomes

Response rate

Time Frame: Up to 3 years

Secondary Outcomes

  • Progression free survival(Up to 3 years)
  • Overall survival(Up to 3 years.)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

Loading locations...

Similar Trials

Completed
Phase 2
Panitumumab and Chemotherapy in Patients With Advanced Colorectal Cancer After Prior Therapy With BevacizumabMucinous Adenocarcinoma of the RectumRecurrent Colon CancerRecurrent Rectal CancerMucinous Adenocarcinoma of the ColonSignet Ring Adenocarcinoma of the ColonSignet Ring Adenocarcinoma of the RectumStage IV Colon CancerStage IV Rectal Cancer
NCT01814501John Hays16
Completed
Phase 2
Panitumumab, Nab-paclitaxel and Carboplatin for HER2 Negative Inflammatory Breast CancerBreast Cancer
NCT01036087M.D. Anderson Cancer Center47
Withdrawn
Phase 2
A Pilot Study to Evaluate the Efficacy and Safety of Neoadjuvant Chemoradiotherapy With Capecitabine, . . .Pancreatic Cancer
NCT01130701University of Massachusetts, Worcester
Completed
Phase 2
Study of the Combination of Panitumumab With Paclitaxel as First-line Treatment of Subjects With Head and Neck CancerHead and Neck Cancer
NCT01264328Grupo Español de Tratamiento de Tumores de Cabeza y Cuello40
Unknown
Phase 2
Efficacy and Safety of Panitumumab Combined With Docetaxel and Cisplatin as a First-line Treatment of Advanced Gastric or Gastroesophageal Junction AdenocarcinomaGastric AdenocarcinomaGastroesophageal Junction Adenocarcinoma
NCT01379807Grupo Gallego de Investigaciones Oncologicas55
First-Line Chemotherapy and Panitumumab in... | Clinical Trial