At a glance
ClinicalIndex Comparison Record- ✓Histologically or cytologically confirmed small cell lung cancer
- ✓Extensive stage disease (extrathoracic metastases, malignant pleural effusion, bilateral/contralateral supraclavicular or contralateral hilar adenopathy)
- ✓At least one measurable lesion ≥20 mm (conventional imaging) or ≥10 mm (spiral CT)
- ✓No prior chemotherapy for SCLC
- ✕Brain metastases, spinal cord compression, or carcinomatous meningitis
- ✕Active second malignancy (except non-melanoma skin cancers)
- ✕Cardiac dysrhythmias, atrial fibrillation, or QTc ≥500 msec
- ✕Class III or IV NYHA heart failure within 12 months
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Combination Chemotherapy With or Without Maintenance Sunitinib Malate (NSC 736511) for Untreated Extensive Stage Small Cell Lung Cancer: A Phase IB/Randomized Phase II Study
In Brief
A Phase 1 clinical trial evaluating Carboplatin, Cisplatin, and 4 other interventions for Extensive Stage Lung Small Cell Carcinoma and Recurrent Lung Small Cell Carcinoma. Completed, enrolled 156 participants across 125 sites.
Signals
Detailed 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.
Study Details
Timeline
Arms & Interventions
Participants will receive the following combination chemotherapy for 4-6 cycles (21 days): Cisplatin 80 mg/m\^2 by IV over 1 hour on day 1 every cycle OR Carboplatin AUC = 5\* by IV Etoposide 100 mg/m\^2 by IV over 1 hour on days 1, 2, and 3 every cycle Maintenance: Following 4-6 cycles of combination chemotherapy, start sunitinib at 150 mg on day 1, then 37.5 daily until disease progression.
Participants will receive the following combination chemotherapy for 4-6 cycles (21 days): Cisplatin 80 mg/m\^2 by IV over 1 hour on day 1 every cycle OR Carboplatin AUC = 5\* by IV Etoposide 100 mg/m2 by IV over 1 hour on days 1, 2, and 3 every cycle Maintenance: Following 4-6 cycles of combination chemotherapy, start placebo at 150 mg on day 1, then 37.5 daily until disease progression.
Interventions
Given IV
Given IV
Given IV
Correlative studies
Given PO
Given PO