Clinical Trial ECOG 2511
- Phase I and Randomized Phase II Double Blind Clinical Trial of Cisplatin and Etoposide in Combination with Veliparib (ABT-888) or Placebo as Frontline Therapy for Extensive Stage Small Cell Lung Cancer
- Principal Investigator
- Jyoti Patel
- Status: Accepting New Patients
- Study Type: Therapeutic, Treatment
- Protocol No:.ECOG 2511
- The purpose of this study is to compare the effects, good and/or bad, of veliparib when combined with the standard commonly-used drugs (cisplatin and etoposide) on patients and their lung cancer.
- This study is for patients who have small cell lung cancer and have not had prior treatment for their cancer. In this study an investigational drug (veliparib) or a placebo (dummy pill) will be given in addition to cisplatin and etoposide. Investigational means that the drug is currently being tested and is not approved for sale in the United States by the Food and Drug Administration (FDA). Cisplatin and etoposide were chosen for this trial because the benefits and risks are well known, and because together they are currently the most effective therapies against small cell lung cancer.
Some of the eligibility criteria include:
- Participants must have small cell lung cancer.
- Participants cannot have had prior chemotherapy or biologic therapy for small cell lung cancer.
- Participants must be 18 or older.
- Description of Treatment
- Participants will be "randomized" to get either veliparib or placebo. Randomization means participants will be randomly assigned to a treatment based on chance, like a flip of a coin. This is a double-blinded study, which means that neither the participant or the study doctor or the study staff will know which treatment each participant is receiving. In addition to the study drug/placebo, participants in both groups will get cisplatin and etoposide as the standard chemotherapy for small cell lung cancer. Both cisplatin and etoposide will be given by vein (IV). The chemotherapy will be given in 3 week cycles. A total of 4 cycles will be given.
- Sara Duffey
Clinical Research and Education Specialist
Robert H. Lurie Comprehensive Cancer Center
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- Randomized Double Blind Placebo Controlled Study of Erlotinib or Placebo in Patients with Completely Resected Epidermal Growth Factor Receptor (EGFR) Mutant Non-Small Cell Lung Cancer (NSCLC)
- A Phase 2, Open-Label, Multicenter, Safety and Efficacy Study of Oral CO-1686 as 2nd Line EGFR-Directed TKI in Patients with Mutant EGFR Non-Small Cell Lung Cancer (NSCLC) with the T790M Resistance Mutation
- 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: 23-May-15 05:18 AM
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