Phase 2
N=156
Cisplatin or Carboplatin, and Etoposide With or Without Sunitinib Malate in Treating Patients With Extensive-Stage Small Cell Lung Cancer
Extensive Stage Lung Small Cell Carcinoma · Recurrent Lung Small Cell Carcinoma
Bottom Line
View on ClinicalTrials.gov: NCT00453154 ↗Enrolled (actual)
156
Serious AEs
25.0%
Results posted
Apr 2015
Primary outcome: Primary: Maximum Tolerated of Sunitinib Combined With Cisplatin and Etoposide (Phase I) — 25 mg/day
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Carboplatin (Drug); Cisplatin (Drug); Etoposide (Drug); Laboratory Biomarker Analysis (Other); Placebo Administration (Other); Sunitinib Malate (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- National Cancer Institute (NCI)
- Primary completion
- Jun 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Tolerated of Sunitinib Combined With Cisplatin and Etoposide (Phase I) |
25 | — |
| PRIMARY Progression-free Survival (Phase II) |
3.7; 2.1 | 0.02 sig |
| SECONDARY Overall Survival |
9.0; 6.9 | — |
| SECONDARY Number of Participants With Overall Tumor Response |
3; 0; 4; 5 | — |
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.
Eligibility Criteria
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 therapy
- Common Toxicity Criteria (CTC) performance status:
- Phase IB: 0-1
- Phase II: 0-2
- No "currently active" second malignancy other than non-melanoma skin cancers
- No history of brain metastases, spinal cord compression, or carcinomatous meningitis
- No ongoing cardiac dysrhythmias, atrial fibrillation, or QTc interval >= 500 msec; the use of agents with proarrhythmic potential (e.g., quinidine, procainamide, disopyramide, sotalol, probucol, pedridel, haloperidol, risperidone, indapamide, flecainide) is not recommended while on protocol therapy
- Patients with class I New York Heart Association (NYHA) are eligible; patients with a history of class II NYHA are eligible, provided they meet the following criteria:
- Patients with a history of class II heart failure who are asymptomatic on treatment
- Patients with prior anthracycline exposure
- Patients who have received central thoracic radiation that included the heart in the radiotherapy port
- Patients with a history of class III or IV NYHA heart failure within 12 months prior to registration are not eligible
- Additionally, no myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft or stenting, cerebrovascular accident including transient ischemic attack, or pulmonary embolism within the last year
- Patients with hypertension that cannot be controlled by medications (> 150/100 mmHg despite optimal medical therapy) are not eligible
- Patients who require use of therapeutic doses of coumarin-derivative anticoagulants such as warfarin are excluded, although doses of up to 2 mg daily are permitted for prophylaxis of thrombosis; Note: Low molecular weight heparin is permitted provided the patient's prothrombin time (PT) international normalized ratio (INR) is = = 1,500/ul
- Platelets >= 100,000/ul
- Creatinine clearance >= 70 ml/min
- Total bilirubin =< 1.5 mg/dl
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x upper limit of normal (ULN) (patients w/ liver metastases may have AST/ALT =< 5 x ULN)
- Partial thromboplastin time (PTT) =< 1.5 x ULN
Data sourced from ClinicalTrials.gov (NCT00453154). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.