Overview

This trial is active, not recruiting.

Conditions non-small cell lung cancer metastatic, nonsquamous nonsmall cell neoplasm of lung
Treatments cisplatin, bevacizumab, pemetrexed
Phase phase 2
Target VEGF
Sponsor Intergroupe Francophone de Cancerologie Thoracique
Start date December 2012
End date January 2016
Trial size 118 participants
Trial identifier NCT01705184, 2012-002647-18, IFCT-1102

Summary

At present, the treatment of non-squamous cell lung cancer is based on chemotherapy with platinum eventually associated with bevacizumab. A new treatment begins at progression.

In colo-rectal metastatic cancer, it was demonstrated that the first-line of treatment could be administered according to a stop and go strategy respecting therapeutic breaks between sequences of identical treatment. During these therapeutic breaks, a treatment of maintenance is possibly better than an absence of treatment. These plans benefit to the patients in terms of efficiency but also in terms of toxicity, in particular neurological.

The question is to know if this strategy is feasible in lung cancer.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Sequence 1 : 3 cycles of cisplatin-pemetrexed-bevacizumab, then maintenance by bevacizumab if disease control. If progression --> Sequence 2 Sequence 2 : 3 cycles of cisplatin-pemetrexed-bevacizumab, then maintenance by bevacizumab-pemetrexed if disease control
cisplatin
75 mg/m2, IV (in the vein) on day 1 of each 21 day cycle. During 3 cycles of each sequence
bevacizumab
7,5 mg/kg, IV (in the vein) on day 1 of each 21 day cycle until progression for each sequence
pemetrexed
500 mg/m2, IV (in the vein) on day 1 of each 21 day cycle. During 3 cycles for the 1st sequence and until progression for the 2nd sequence.

Primary Outcomes

Measure
Feasibility
time frame: After 3 cycles

Secondary Outcomes

Measure
Control rate after the 2nd sequence
time frame: After 3 cycles
Response rate after the 1st sequence
time frame: After 3 cycles
Overall survival
time frame: 12 months
Quality of life
time frame: During Sequence 2 : at the beginning and after 3 cycles

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Non squamous non small cell lung cancer histologically or cytologically confirmed with no EGFR mutation. - Stage IV NSCLC. Patient with cerebral metastasis are eligible if the metastasis is asymptomatic. - Measurable disease (recist criteria) - Age ≥18 years - PS0 or 1 Exclusion Criteria: - Mixed cancer small cells and non small cells or squamous lung cancer . EGFR mutated cancer - History of malignant tumour excepted cervical and basocellular cancer and cancer cured for at least 5 years. - Tumor invaded the big vessels or the proximal visible in TDM. - History of adjuvant or neoadjuvant chemotherapy

Additional Information

Official title Phase II Study Evaluating the Interest of the Re-introduction of Pemetrexed and Platinum (Cisplatin or Carboplatin) With Prolonged Angiogenic Blocking by Bevacizumab in Non Squamous Non Small Cell Lung Cancer of Advanced Stage.
Principal investigator Jaafar BENNOUNA, MD
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Intergroupe Francophone de Cancerologie Thoracique.