Re-introduction of Pemetrexed and Cisplatin With Prolonged Angiogenic Blocking by Bevacizumab in Advanced Lung Cancer.

Sponsor
Intergroupe Francophone de Cancerologie Thoracique
Study ID
NCT01705184
Phase
PHASE2
Status
Completed

Conditions

  • Non-small Cell Lung Cancer Metastatic
  • Nonsquamous Nonsmall Cell Neoplasm of Lung

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cisplatin — DRUG
    75 mg/m2, IV (in the vein) on day 1 of each 21 day cycle. During 3 cycles of each sequence
  • Bevacizumab — DRUG
    7,5 mg/kg, IV (in the vein) on day 1 of each 21 day cycle until progression for each sequence
  • Pemetrexed — DRUG
    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.

Study Details

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.

Key Dates

First listed
Oct 12, 2012
Start date
Dec 31, 2012
Status verified
Mar 2023
Primary completion
Jan 31, 2016
Completion
Oct 31, 2017

Study Design

Enrollment
120 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: BUCiL
    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

Primary Outcome Measure

Feasibility [ Time Frame: After 3 cycles ]

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