Cisplatin or Carboplatin, and Etoposide With or Without Sunitinib Malate in Treating Patients Wit… (NCT00453154) | Clinical Trial Compass
CompletedPhase 1/2
Cisplatin or Carboplatin, and Etoposide With or Without Sunitinib Malate in Treating Patients With Extensive-Stage Small Cell Lung Cancer
United States156 participantsStarted 2007-03-15
Plain-language summary
This partially randomized phase I/II trial studies the side effects and best dose of sunitinib malate and to see how well it works when given together with cisplatin or carboplatin and etoposide in treating patients with extensive-stage small cell lung cancer. Drugs used in chemotherapy, such as cisplatin, carboplatin, and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. It is not yet known whether cisplatin or carboplatin and etoposide are more effective when given with or without sunitinib malate in treating 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:
* All patients must have histologically or cytologically documented small cell lung cancer
* Eligible disease stages: the extensive disease classification for this protocol includes all patients with disease sites not defined as limited stage; limited stage disease category includes patients with disease restricted to one hemithorax with regional lymph node metastases, including hilar, ipsilateral and contralateral mediastinal, and/or ipsilateral supraclavicular nodes; extensive stage patients are defined as those patients with extrathoracic metastatic, malignant pleural effusion, bilateral or contralateral supraclavicular adenopathy or contralateral hilar adenopathy
* All patients must have measurable disease:
* Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as \>= 20 mm with conventional techniques or as \>= 10 mm with spiral computed tomography (CT) scan
* Lesions that are considered non-measurable, which would make the patient not eligible, include the following:
* Bone lesions
* Leptomeningeal disease
* Ascites
* Pleural/pericardial effusion
* Lymphangitis cutis/pulmonis
* Abdominal masses that are not confirmed and followed by imaging techniques
* Cystic lesions
* No prior chemotherapy for small cell lung cancer (SCLC)
* Radiation therapy must have been completed at least one week before initiation of protocol therap…
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 tested adding sunitinib to standard platinum-based chemotherapy — since it's a Phase 1/2 study, what do the results tell us about whether that combination was safe and whether it actually improved progression-free survival for extensive-stage small cell lung cancer?
2The trial used either cisplatin or carboplatin together with etoposide — based on my specific health situation, which of those two platinum drugs would my care team recommend, and why?
3Since this trial is now completed, has the data been published, and does my doctor think the findings are relevant to the treatment options available to me today?
4Small cell lung cancer can move quickly — given that this was a Phase 1/2 study still working out safe dosing when it started, how confident is my doctor in the safety profile of adding sunitinib to chemotherapy based on what this trial found?
5Are there currently other trials or approved treatments for extensive-stage small cell lung cancer that my doctor thinks I should consider alongside or instead of what was studied here?
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
Maximum Tolerated of Sunitinib Combined With Cisplatin and Etoposide (Phase I)