Clinical Trial ECOG 5508
- Randomized Phase III Study of Maintenance Therapy with Bevacizumab, Pemetrexed, or a Combination of Bevacizumab and Pemetrexed Following Carboplatin, Paclitaxel and Bevacizumab for Advanced Non-Squamous NSCLC
- Principal Investigator
- Jyoti Patel
- Status: CLOSED
- Study Type: Therapeutic, Treatment
- Protocol No:.ECOG 5508
- The primary purpose of this research is to find out the best maintenance therapy for patients with advanced stage non-small cell lung cancer.
- This study is for patients who have have non-small cell lung cancer (NSCLC) that has spread. The standard treatment for patients with advanced stage NSCLC is four to six cycles of chemotherapy. Research has shown that continuing patients on treatment after six cycles of chemotherapy leads to unacceptable toxicity (adverse events), so continuing chemotherapy is not the best option. Instead, maintenance therapy is often used. ‘Maintenance therapy’ is the administration of therapy following initial chemotherapy. Previous research has shown that that several drugs can be effective as maintenance therapy for NSCLC. This study will compare several drugs to try to determine which is best.
Some of the eligibility criteria include:
- Participants must have non-small cell lung cancer that is at an advanced stage.
- Participants may not have any prior systemic chemotherapy for advanced stage lung cancer; although, prior chemotherapy for early stage cancer (adjuvant chemotherapy) or radiation therapy is permitted.
- Participants must be 18 years of age or older.
- Description of Treatment
- Study participants will receive the standard combination of carboplatin, paclitaxel and bevacizumab for a maximum of 4 cycles of therapy (1 cycle= 21 days). This is called Induction Therapy. After 4 cycles of therapy, if the participant's cancer remains under control, he or she will be "randomized" into one of three study groups. Participants in group 1 (often called "Arm A") will be treated with bevacizumab every 3 weeks. The treatment will be continued as long as the cancer is under control and there are no intolerable side effects. Participants in group 2 (often called "Arm B") will be treated with pemetrexed every 3 weeks. The treatment will be continued as long as the cancer is under control and there are no intolerable side effects. Participants in group 3 (often called “Arm C”) will be treated with bevacizumab and pemetrexed every 3 weeks. The treatment will be continued as long as the cancer is under control and there are no intolerable side effects.
- Sara Duffey
Clinical Research and Education Specialist
Robert H. Lurie Comprehensive Cancer Center
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- A Randomized, Open-Label, Phase II Study of CO-1686 or Erlotinib as First-Line Treatment of Patients with EGFR-Mutant Advanced Non-Small Cell Lung Cancer (NSCLC)
- A Phase II, Multicenter, Single-Arm Study of MPDL3280a in Patients with PD-L1–Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer
- An Open-label, Randomized Phase IIb/III Active Control Study of Second-line HyperAcute®-Lung (tergenpumatucel-L) Immunotherapy versus Docetaxel in Progressive or Relapsed Non-Small Cell Lung Cancer
- Phase II/III Biomarker-Driven Master Protocol for Second Line Therapy of Squamous Cell Lung Cancer
- A Randomized Phase II Study of Individualized Combined Modality Therapy for Stage III Non-Small Cell Lung Cancer (NSCLC)
last updated: 28-Jul-15 03:23 AM
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