Phase 2
N=89
Sorafenib in Treating Patients With Extensive Stage Small Cell Lung Cancer
Extensive Stage Small Cell Lung Cancer · Recurrent Small Cell Lung Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00182689 ↗Enrolled (actual)
89
Serious AEs
15.9%
Results posted
Sep 2012
Primary outcome: Primary: Objective Response (Confirmed and Unconfirmed, Complete and Partial Responses Per RECIST) — 11; 2 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- sorafenib tosylate (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- National Cancer Institute (NCI)
- Primary completion
- Oct 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Objective Response (Confirmed and Unconfirmed, Complete and Partial Responses Per RECIST) |
11; 2 | — |
| SECONDARY Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug |
1; 0; 0; 1; 2; 1 | — |
| SECONDARY Overall Survival |
6.7; 5.3 | — |
Summary
This phase II trial is studying how well sorafenib works in treating patients with extensive stage small cell lung cancer. Sorafenib may stop the growth of small cell lung cancer by blocking blood flow to the tumor and by blocking some of the enzymes needed for cell growth.
Eligibility Criteria
Inclusion Criteria
- Patients must have histologically or cytologically-confirmed diagnosis of small cell lung cancer and must have extensive disease with progression or recurrence after receiving a standard first-time regimen containing either cisplatin or carboplatin; patients who receive primary curative chemoradiation therapy for limited disease, but who recur within the primary tumor site, previously radiated field or with distant metastases are also allowed to participate; diagnosis based on sputum cytology is acceptable if confirmation by an independent pathologic review at the institution is documented; patients who have clinical evidence of recurrent small cell lung cancer do not require a confirmatory biopsy to be eligible for this trial
- Patients must have measurable disease per RECIST criteria; patients must have evidence of disease by plain radiographs, CT scan or MRI scan; all x-rays/scans to assess measurable disease must have been performed within 28 days prior to registration; all other required test to assess non-measurable disease must be performed within 42 days prior to registration; all disease must be assessed
- Patients must have been previously treated with exactly one regimen; this must have included cisplatin or carboplatin; in addition, information must be available to place the patient in one of the two following categories:
- Platinum sensitive disease: defined as an initial response to platinum-based chemotherapy who subsequently progressed > 90 days after last platinum treatment; best response to platinum-based treatment: CR, PR, stable or progression while on treatment (circle one); NOTE: Prior chemotherapy must have been completed at least 90 days prior to registration OR
- Platinum refractory disease; no response to platinum-based chemotherapy, progression during platinum-based therapy, or progression within 90 days of completing platinum-based therapy
- Patient may have receive previous radiation therapy, but it must have been completed at least 21 days prior to registration and the patient should have recovered from all associated toxicities; there must be no plans for the patients to receive concurrent radiation therapy to measurable lesions; measurable disease may be present inside the area of prior radiation therapy provided that the lesion is demonstrated to be progressing by CT scan or there is measurable disease outside the prior radiation field
- Patients may have received prior surgery provided that at least 14 days have elapsed since surgery (thoracic or other major surgeries) and the patient has recovered from all associated toxicities; patients must have disease outside the area of previous surgical resection or a new lesion must be present
- CORRELATIVE SCIENCE STUDIES: Institutions must have IRB approval of S9925 (the Lung Cancer Specimen Repository); patients must be offered participation in S9925; with the patient's consent, specimens will be submitted for testing via S9925; patients must be registered separately to S9925 in order for institutions to receive credit for specimen submission
- Serum creatinine = = 60 cc/min
- Bilirubin = = 1,500/uL
- Platelet count >= 100,000/uL
- Patients must have a Zubrod performance status 0-1
- Patients with known brain and/or leptomeningeal metastases are eligible only if he/she is asymptomatic, without deficits on neurologic exam and is not receiving corticosteroid therapy to control symptoms; only a non-enzyme inducing anticonvulsant (e.g., Keppra) will be permitted for those patients requiring anticonvulsants; all patients must have a pretreatment CT or MRI scan of the brain to evaluate CNS disease within 28 days prior to registration
- Any ongoing requirement for systemic corticosteroid therapy is not permitted; topical and/or inhaled steroids are allowed
- Patients must either be able to swallow and/or receive enteral medications via gastrostomy feeding tube; patients with intractable nausea or vomiting are not eligible; patients
Data sourced from ClinicalTrials.gov (NCT00182689). 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.