Sorafenib in Treating Patients With Extensive Stage Small Cell Lung Cancer

NCT00182689 | Completed Phase 2 Results

• 3 other identifiers: NCI-2012-03074U10CA032102S0435
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Extensive Stage Small Cell Lung Cancer; Recurrent Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Objective Response (Confirmed and Unconfirmed, Complete and Partial Responses Per RECIST)

  Complete Response (CR) is a complete disappearance of all measurable and non-measurable disease. No new lesions, no disease related symptoms. Normalization of markers and other abnormal lab values. Partial Response (PR) is greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions. No unequivocal progression of non-measurable disease. No new lesions. Confirmation of CR or PR means a repeat scan at least 4 weeks apart documented before progression or symptomatic deterioration.

  8 weeks to 2 years

Secondary Outcomes (2)

• Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug

  Patients were assessed for adverse events after completion of every 28-day cycle.

• Overall Survival

  0 - 2 years

Study Arms (1)

Treatment (sorafenib tosylate)

EXPERIMENTAL

Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Drug: sorafenib tosylate

Interventions

sorafenib tosylate DRUG

Given orally

Also known as: BAY 43-9006, BAY 43-9006 Tosylate Salt, BAY 54-9085, Nexavar, SFN

Treatment (sorafenib tosylate)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 =\< the institutional upper limit of normal OR creatinine clearance \>= 60 cc/min
• Bilirubin =\< 2 x the institutional upper limit of normal
• Alkaline phosphatase =\< 2 x the institutional upper limit of normal
• SGOT or SGPT =\< 2 x the institutional upper limit of normal
• PTT and either PT or INR \< 1.5 x the institutional upper limit of normal (except in patients who are on warfarin \[Coumadin or heparin\] obtained within 28 days prior to registration); patients who receive anti-coagulation treatment with an agent such as warfarin or heparin, prophylactically or therapeutically, will be allowed to participate
• Patients must not have any evidence of bleeding diathesis
• ANC \>= 1,500/uL

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

SWOG

Portland, Oregon, 97239, United States

Location

Related Publications (1)

• Lara PN Jr, Moon J, Redman MW, Semrad TJ, Kelly K, Allen JW, Gitlitz BJ, Mack PC, Gandara DR. Relevance of platinum-sensitivity status in relapsed/refractory extensive-stage small-cell lung cancer in the modern era: a patient-level analysis of southwest oncology group trials. J Thorac Oncol. 2015 Jan;10(1):110-5. doi: 10.1097/JTO.0000000000000385.

  PMID: 25490004 DERIVED

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

Sorafenib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Study Statistician
• Organization: SWOG Statistical Center

206-667-4623

Study Officials

• Barbara Gitlitz

  SWOG Cancer Research Network

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2005
• First Posted: September 16, 2005
• Study Start: July 1, 2005
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: May 21, 2014
• Results First Posted: September 19, 2012

Record last verified: 2012-12

Locations

US (1)