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Sorafenib, Cisplatin, and Etoposide in Treating Patients With Extensive-Stage Small Cell Lung Cancer

Primary Purpose

Lung Cancer

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
cisplatin
etoposide
sorafenib tosylate
Sponsored by
Afshin Dowlati, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring extensive stage small cell lung cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS:

  • Diagnosis of extensive-stage small cell lung cancer

  • No untreated brain metastases

    • No active symptoms related to brain metastases

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • Hemoglobin ≥ 9.0 g/dL
  • ANC ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • ALT and AST ≤ 2.5 times ULN (≤ 5 times ULN for patients with liver involvement)
  • Creatinine ≤ 1.5 times ULN
  • INR < 1.5 or PT/PTT normal

  • No history of cardiac disease, including any of the following:

    • NYHA class III-IV congestive heart failure
    • Unstable angina (i.e., anginal symptoms at rest)
    • Onset of angina within the past 3 months
    • Myocardial infarction within the past 6 months
  • No cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
  • No uncontrolled hypertension, defined as systolic blood pressure (BP) > 150 mm Hg or diastolic BP > 90 mm Hg, despite optimal medical management
  • No thrombolic or embolic events, such as cerebrovascular accident or transient ischemic attacks, within the past 6 months
  • No pulmonary hemorrhage/bleeding event ≥ CTCAE grade 2 within the past 4 weeks
  • No other hemorrhage/bleeding event ≥ CTCAE grade 3 within the past 4 weeks
  • No known HIV infection or chronic hepatitis B or C infection
  • No active clinically serious infection > CTCAE grade 2
  • No serious non-healing wound, ulcer, or bone fracture
  • No evidence or history of bleeding diathesis or coagulopathy
  • No significant traumatic injury within the past 4 weeks
  • No known or suspected allergy to sorafenib tosylate or to any other drug given during the study
  • No condition that would impair the patient's ability to swallow whole pills
  • No known malabsorption problem
  • Not pregnant or nursing
  • Negative pregnancy test

  • Fertile patients must use effective barrier contraception

    • Male patients must use effective contraception during and for ≥ 3 months after completion of sorafenib tosylate

PRIOR CONCURRENT THERAPY:

  • Prior radiotherapy to the brain allowed
  • No prior chemotherapy
  • More than 4 weeks since prior major surgery or open biopsy
  • No concurrent Hypericum perforatum (St. John's wort) or rifampin
  • Concurrent anti-coagulation treatment, such as warfarin or heparin, allowed

Sites / Locations

  • Columbia Presbyterian
  • Lake/University Ireland Cancer Center
  • Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
  • MetroHealth Medical Center
  • CCF-Fairview Hospital
  • UHHS Chagrin Highlands Medical Center
  • Southwest General Health Center
  • UHHS Westlake Medical Center
  • Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
  • UH-Monarch
  • UH-Firelands

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Sorafenib, Cisplatin, and Etoposide

Arm Description

Outcomes

Primary Outcome Measures

Progression-free Survival(PFS)
PFS is defined as the duration of time from start of treatment to time of progression or death, whichever comes first.

Secondary Outcome Measures

Median Overall Survival
Overall survival is measured from the date of chemotherapy treatment (date of cycle 1 of induction chemotherapy) until death and censored at the date of last follow-up for survivors.
Response Rate
The Response Evaluation Criteria in Solid Tumors (RECIST) were used to assess response to the treatment. Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started
Safety
Number of patients that experienced grade 3-4-5 treatment related toxicities. Toxicity was graded by the National Cancer Institute Common Terminology Criteria version 3.0.

Full Information

First Posted
July 31, 2008
Last Updated
November 5, 2014
Sponsor
Afshin Dowlati, MD
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00726986
Brief Title
Sorafenib, Cisplatin, and Etoposide in Treating Patients With Extensive-Stage Small Cell Lung Cancer
Official Title
Phase II Trial of Sorafenib in Conjunction With Chemotherapy and as Maintenance Therapy in Extensive-Stage Small Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Terminated
Why Stopped
Extreme toxicity
Study Start Date
July 2008 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Afshin Dowlati, MD
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
RATIONALE: Sorafenib 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. Drugs used in chemotherapy, such as cisplatin and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving sorafenib together with combination chemotherapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving sorafenib together with cisplatin and etoposide works in treating patients with extensive-stage small cell lung cancer.
Detailed Description
OBJECTIVES: To evaluate the 1-year progression-free survival of patients with extensive-stage small cell lung cancer treated with sorafenib tosylate in combination with cisplatin and etoposide. To evaluate the 1-year overall survival and response rate in these patients. To evaluate the safety of these drugs in these patients. OUTLINE: This is a multicenter study. Patients receive cisplatin IV over 30-60 minutes on day 1 and etoposide IV over 60 minutes on days 1-3. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients also receive oral sorafenib tosylate twice daily beginning on day 1 of course 1 and continuing for up to 1 year in the absence of disease progression or unacceptable toxicity.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
extensive stage small cell lung cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sorafenib, Cisplatin, and Etoposide
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Description
Cisplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Intervention Type
Drug
Intervention Name(s)
etoposide
Intervention Description
Etoposide IV over 60 minutes on days 1-3. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Intervention Type
Drug
Intervention Name(s)
sorafenib tosylate
Intervention Description
Oral sorafenib tosylate twice daily beginning on day 1 of course 1 and continuing for up to 1 year in the absence of disease progression or unacceptable toxicity.
Primary Outcome Measure Information:
Title
Progression-free Survival(PFS)
Description
PFS is defined as the duration of time from start of treatment to time of progression or death, whichever comes first.
Time Frame
1-year
Secondary Outcome Measure Information:
Title
Median Overall Survival
Description
Overall survival is measured from the date of chemotherapy treatment (date of cycle 1 of induction chemotherapy) until death and censored at the date of last follow-up for survivors.
Time Frame
1-year
Title
Response Rate
Description
The Response Evaluation Criteria in Solid Tumors (RECIST) were used to assess response to the treatment. Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started
Time Frame
reevaluated for response every 8 weeks
Title
Safety
Description
Number of patients that experienced grade 3-4-5 treatment related toxicities. Toxicity was graded by the National Cancer Institute Common Terminology Criteria version 3.0.
Time Frame
Treatment repeats every 21 days for 4 courses in the absence of unacceptable toxicity.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Diagnosis of extensive-stage small cell lung cancer No untreated brain metastases No active symptoms related to brain metastases PATIENT CHARACTERISTICS: ECOG performance status 0-2 Hemoglobin ≥ 9.0 g/dL ANC ≥ 1,500/mm³ Platelet count ≥ 100,000/mm³ Total bilirubin ≤ 1.5 times upper limit of normal (ULN) ALT and AST ≤ 2.5 times ULN (≤ 5 times ULN for patients with liver involvement) Creatinine ≤ 1.5 times ULN INR < 1.5 or PT/PTT normal No history of cardiac disease, including any of the following: NYHA class III-IV congestive heart failure Unstable angina (i.e., anginal symptoms at rest) Onset of angina within the past 3 months Myocardial infarction within the past 6 months No cardiac ventricular arrhythmias requiring anti-arrhythmic therapy No uncontrolled hypertension, defined as systolic blood pressure (BP) > 150 mm Hg or diastolic BP > 90 mm Hg, despite optimal medical management No thrombolic or embolic events, such as cerebrovascular accident or transient ischemic attacks, within the past 6 months No pulmonary hemorrhage/bleeding event ≥ CTCAE grade 2 within the past 4 weeks No other hemorrhage/bleeding event ≥ CTCAE grade 3 within the past 4 weeks No known HIV infection or chronic hepatitis B or C infection No active clinically serious infection > CTCAE grade 2 No serious non-healing wound, ulcer, or bone fracture No evidence or history of bleeding diathesis or coagulopathy No significant traumatic injury within the past 4 weeks No known or suspected allergy to sorafenib tosylate or to any other drug given during the study No condition that would impair the patient's ability to swallow whole pills No known malabsorption problem Not pregnant or nursing Negative pregnancy test Fertile patients must use effective barrier contraception Male patients must use effective contraception during and for ≥ 3 months after completion of sorafenib tosylate PRIOR CONCURRENT THERAPY: Prior radiotherapy to the brain allowed No prior chemotherapy More than 4 weeks since prior major surgery or open biopsy No concurrent Hypericum perforatum (St. John's wort) or rifampin Concurrent anti-coagulation treatment, such as warfarin or heparin, allowed
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Afshin Dowlati, MD
Organizational Affiliation
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nathan Pennell, MD
Organizational Affiliation
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia Presbyterian
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Lake/University Ireland Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44060
Country
United States
Facility Name
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106-5065
Country
United States
Facility Name
MetroHealth Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States
Facility Name
CCF-Fairview Hospital
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44111
Country
United States
Facility Name
UHHS Chagrin Highlands Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
Southwest General Health Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44130
Country
United States
Facility Name
UHHS Westlake Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44145
Country
United States
Facility Name
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
UH-Monarch
City
Mayfield Heights
State/Province
Ohio
ZIP/Postal Code
44124
Country
United States
Facility Name
UH-Firelands
City
Sandusky
State/Province
Ohio
ZIP/Postal Code
44870
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Sorafenib, Cisplatin, and Etoposide in Treating Patients With Extensive-Stage Small Cell Lung Cancer

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