Lung CancerPhase 2NCT00726986

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

A Phase 2 study testing cisplatin, etoposide and sorafenib tosylate in people with Lung Cancer, run by Afshin Dowlati, MD at 11 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Lung Cancer
What is being tested?: cisplatin, etoposide and sorafenib tosylate
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 18 participants
Where: 11 sitesUnited States
Study dates: Jul 2008to Jul 2012
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

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

Trial locations and contacts

11 sites in 1 country.

City, postcode or hospital

11 sites in 1 country

United States11 sites

Lake/University Ireland Cancer Center
Cleveland, Ohio, 44060
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106-5065
MetroHealth Medical Center
Cleveland, Ohio, 44109
CCF-Fairview Hospital
Cleveland, Ohio, 44111
UHHS Chagrin Highlands Medical Center
Cleveland, Ohio, 44122
Southwest General Health Center
Cleveland, Ohio, 44130
UHHS Westlake Medical Center
Cleveland, Ohio, 44145
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, 44195
UH-Monarch
Mayfield Heights, Ohio, 44124
Columbia Presbyterian
New York, New York, 10032
UH-Firelands
Sandusky, Ohio, 44870

Other trials in United States

About this study

Official title: Phase II Trial of Sorafenib in Conjunction With Chemotherapy and as Maintenance Therapy in Extensive-Stage Small Cell Lung Cancer

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.

Read the 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.

Conditions: Lung Cancer
Being tested: cisplatin, etoposide, sorafenib tosylate
Keywords: extensive stage small cell lung cancer
Medical subject headings: Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

cisplatinDrug
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.
etoposideDrug
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.
sorafenib tosylateDrug
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.

Study groups in NCT00726986
Study group	Role	What they receive
Sorafenib, Cisplatin, and Etoposide	Experimental	Not described Receives: Drug: cisplatin; Drug: etoposide; Drug: sorafenib tosylate

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 1-year

Secondary outcomes (3)

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.
Measured: 1-year
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
Measured: reevaluated for response every 8 weeks
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.
Measured: Treatment repeats every 21 days for 4 courses in the absence of unacceptable toxicity.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2008Jul 2012

First posted1 Aug 2008 (estimated)
Study startJul 2008
Primary completionJul 2012
Study completionJul 2012

Why it stopped: Extreme toxicity

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Lung CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00726986
Sponsor's protocol ID: CASE8507
Other IDs: P30CA043703, CASE8507, CASE-8507-CC486
Status last verified: Nov 2014
First submitted: 31 Jul 2008
Last updated: 19 Nov 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Lung Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase II Trial of Sorafenib in Conjunction With Chemotherapy and as Maintenance Therapy in Extensive-Stage Small Cell Lung Cancer
ClinicalTrials.gov ID: NCT00726986
Acronym / sponsor ID: CASE8507
Conditions: Lung Cancer
Keywords: extensive stage small cell lung cancer
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Extreme toxicity
Enrolment: 18 participants (actual)
Lead sponsor: Afshin Dowlati, MDUniversity, hospital or other
Collaborators: National Cancer Institute (NCI)
Study start: Jul 2008
Primary completion: Jul 2012 (actual)
Study completion: Jul 2012 (actual)
First posted: 1 Aug 2008 (estimated)
Results: Posted 4 Aug 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Sorafenib, Cisplatin, and Etoposide	Experimental	Drug: cisplatin, Drug: etoposide, Drug: sorafenib tosylate

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
cisplatinCisplatin 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.	Drug	Sorafenib, Cisplatin, and Etoposide
etoposideEtoposide 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.	Drug	Sorafenib, Cisplatin, and Etoposide
sorafenib tosylateOral 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.	Drug	Sorafenib, Cisplatin, and Etoposide

Primary outcome

Progression-free Survival(PFS)
Time frame: 1-year
PFS is defined as the duration of time from start of treatment to time of progression or death, whichever comes first.

3 secondary outcomes

Median Overall Survival
Time frame: 1-year
Response Rate
Time frame: reevaluated for response every 8 weeks
Safety
Time frame: Treatment repeats every 21 days for 4 courses in the absence of unacceptable toxicity.

Results and safety

Results posted to the registry on 4 Aug 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sorafenib, Cisplatin, and Etoposide	18	3

Primary outcome: Progression-free Survival(PFS)

Time frame: 1-year. Median (95% Confidence Interval). Unit: months

Measure	Sorafenib, Cisplatin, and Etoposide n = 16
Value	5.1 (1.2 to 8.2)

Population analysed: Patients who received at least one dose of the study drug were considered evaluable for both toxicity and response.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Patients were followed for adverse events while on treatment and post-treatment follow up for up to 1 year.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Sorafenib, Cisplatin, and Etoposide	14 of 17 (82.4%)	17 of 17 (100%)	Not reported

Limitations and caveats (from the sponsor): This study was terminated after enrolling 18 patients on the basis of excessive toxicity observed and preliminary efficacy data showing that study was unlikely to meet primary end point.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
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Streamlined Geriatric and Oncological Evaluation Based On IC Technology
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RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Afshin Dowlati, MD principal investigator

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Nathan Pennell, MD principal investigator

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

11 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing cisplatin, etoposide and sorafenib tosylate in people with Lung Cancer, run by Afshin Dowlati, MD at 11 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 19 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free Survival(PFS) (time frame: 1-year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00726986.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2014.