Temozolomide With or Without Veliparib in Treating Patients With Relapsed or Refractory Small Cel… (NCT01638546) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Temozolomide With or Without Veliparib in Treating Patients With Relapsed or Refractory Small Cell Lung Cancer
United States97 participantsStarted 2012-07-27
Plain-language summary
This randomized phase II trial studies how well temozolomide with or without veliparib works in treating patients with small cell lung cancer that has returned or does not respond to treatment. Temozolomide works by damaging molecules inside the cancer cells, such as deoxyribonucleic acid (DNA), that are needed for cancer survival and growth. Veliparib may stop the growth of tumor cells by blocking proteins that are needed for repairing the damaged DNA and it may also help temozolomide to kill more cancer cells. It is not yet know whether temozolomide is more effective with or without veliparib in treating patients with relapsed or refractory small cell lung cancer.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients must have histologically or cytologically confirmed small cell lung cancer; confirmation will be done at Memorial Sloan-Kettering Cancer Center (MSKCC) or locally for participating sites
* Patients' disease has relapsed or progressed after one or two prior chemotherapy regimens, one of which must have been an etoposide-platinum doublet; eligible patients will be defined as follows:
* "Sensitive" disease: patients who had one previous line of chemotherapy and maintained an appropriate response for \> 60 days
* "Refractory" disease: those patients with either (a) no response to first-line chemotherapy or progression =\< 60 days after completing treatment, or (b) "sensitive" or "refractory" disease in need of third-line therapy (i.e. completed or failed two previous lines of chemotherapy)
* Eastern Cooperative Oncology Group (ECOG) performance status =\< 1 (Karnofsky \>= 70%)
* Patients with asymptomatic brain metastases that do not require immediate whole brain radiation therapy and are on stable doses of steroids are allowed
* Patients must have measurable disease, which is defined as at least one lesion that can be accurately measured in at least one dimension on a computed tomography (CT) scan as per RECIST version 1.1; brain metastases can be considered measurable disease if they meet this criterion
* Absolute neutrophil count \>= 1,500/mcL
* Platelets \>= 100,000/mcL
* Hemoglobin \>= 8.5 g/dL; the use of transfusion to achieve this crit…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing temozolomide with or without a second drug called veliparib for small cell lung cancer that has come back or stopped responding to treatment — is my cancer's situation similar enough to what this trial is designed for that it would even be worth discussing with my care team?
2Since this is a Phase 2 trial, what does that mean for how much is already known about whether this combination is safe and whether it actually works for patients like me?
3The trial is no longer enrolling new patients — does that mean results might be available soon, and could those findings change what treatment options you'd recommend for me right now?
4The main thing this study is measuring is how long patients go without the disease getting worse — how does that goal compare to what I should realistically hope for from standard treatments that are already available to me?
5Temozolomide is a chemotherapy drug sometimes used in other cancers — what side effects or risks would you want me to understand before considering a regimen that includes it, especially given that my cancer has already relapsed or stopped responding?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Progression-free Survival, Calculated as the Proportion of Patients Alive and Without Evidence of Disease
Timeframe: From randomization to time of progression or death, whichever occurs first, assessed at 4 months