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OpenTrials
Completed

NCT Number: NCT01705184

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

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.

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Key information

Conditions

Non-small Cell Lung Cancer Metastatic Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Nonsquamous Nonsmall Cell Neoplasm of Lung Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Avignon - Institut Sainte-Catherine, Avignon, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Feasibility

    Time frame: After 3 cycles

    Number of patients receiving 3 cycles of chemotherapy with full-dose platinum in the 2nd sequence

Secondary outcomes

  1. Control rate after the 2nd sequence

    Time frame: After 3 cycles

  2. Response rate after the 1st sequence

    Time frame: After 3 cycles

  3. Overall survival

    Time frame: 12 months

  4. Quality of life

    Time frame: During Sequence 2 : at the beginning and after 3 cycles

Sponsors and collaborators

Lead sponsor

Intergroupe Francophone de Cancerologie Thoracique

Other

Registry information

Official study 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.

Acronym: BUCiL

Important dates

Study start
2012
Primary completion
2016
Study completion
2017
First posted
Oct 12, 2012
Registry last updated
Mar 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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