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Small Cell Lung CancerPhase 2NCT01159327

Study of Sorafenib Maintenance in Patients With ED-SCLC After Response to Induction Chemotherapy

A Phase 2 study testing Sorafenib in people with Small Cell Lung Cancer, run by National Cancer Center, Korea at 1 site in South Korea.

Terminated

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

Official record
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Trial summary

A Phase I trial of weekly topotecan in combination with sorafenib in treatment of relapsed Small cell lung cancer (SCLC) has been commenced. In the present randomized phase 2 study, the investigators will research whether Sorafenib maintenance prolongs progression free survival (PFS) and overall survival (OS) in… Read more about this study

Who is it for?
Ages 18 months and older
Conditions the study is for
Small Cell Lung Cancer
What is being tested?
Sorafenib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
13 participants
Where
1 siteSouth Korea
Study dates
Dec 2010to Jun 2013
Phase
Phase 2
Are there results?
None posted in the registry

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 months and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Histologically or cytologically confirmed ED-SCLC patients who have achieved a complete or partial response after four to six cycles of platinum based induction chemotherapy.
  • Extensive stage SCLC is defined as disease not meaning the definition of limited stage disease
  • Previous radiotherapy is allowed only if < 30% of marrow bearing bones were irradiated and if radiotherapy was completed at least 2 weeks prior to enrollment and the patient has recovered from all adverse effects of prior radiotherapy.
  • Age >18 years.
  • Written informed consent that is consistent with ICH-GCP guidelines
  • Life expectancy of greater than 3 months.
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  • ECOG performance status 2 (Karnofsky ≥50%).
  • Ability to swallow oral medication
  • Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of treatment
  • Both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial and during the first 3 months after the completion of trial
  • Adequate bone marrow, liver and renal function

Who cannot join

  • History of cardiac disease/ HIV infection / chronic hepatitis B or C / of organ allograft
  • Active clinically serious infections
  • Patients with seizure disorder requiring medication or evidence or history of bleeding diathesis or coagulopathy
  • Patients undergoing renal dialysis
  • Pulmonary hemorrhage/ bleeding event ≥ CTCAE grade 2 within four weeks
  • Any other hemorrhage/ bleeding event ≥ CTCAE grade 3 within four weeks
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  • Non-healing wound, ulcer or bone fracture
  • Thrombotic or embolic venous or arterial events of study drug
  • Previous or concurrent cancer that is distinct in histology of primary site, EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (Ta, Tis, T1). Any cancer curatively treated >3 years prior to entry is permitted.
  • Substance abuse, medical, psychological or social conditions that may interfere with the subject's participation in the study or evaluation of the study results
  • Known or suspected allergy or any other contraindication for Sorafenib administration
  • Pregnant or breast-feeding women.
  • Any disease which could affect the evaluation of the study drug
  • Any condition that is unstable or could jeopardize the safety of the subject and their compliance in the study
  • Any condition which could affect the absorption or pharmacokinetics of the Study drug including any type of gastrointestinal resection or surgery
  • Uncontrolled symptomatic brain metastasis
  • Excluded therapies and medications, previous and concomitant:
  • Investigational drug or device therapy including outside of this trial during or within 4 weeks prior to study entry (signing Informed Consent).
  • The toxicity effects of previous antitumor chemotherapy or immunotherapy must be resolved to less than CTC Grade 2 level (exception: alopecia).
  • Prior treatment with other VEGFR inhibitors (i.e. sunitinib, thalidomide, vandetanib and other experimental agents of this class).
  • Major surgery within 4 weeks prior to start of study (Informed Consent signature). Minimal invasive biopsy is allowed.
  • Use of biologic response modifiers, such as G-CSF, within 3 weeks prior to study entry. [Therapeutic G-CSF and other hematopoietic growth factors may be used in the management of acute toxicity such as febrile neutropenia when clinically indicated or at the discretion of the investigator, however they may not be substituted for a required dose reduction].
  • Any agents which could affect the absorption or pharmacokinetics of the study drug
  • Prior exposure to the study drug
  • Therapeutic anticoagulation with vitamin K antagonists such as warfarin, or with heparins or heparinoids. Prophylactic low dose warfarin (1 mg po qd) is permitted if the INR (International normalized ratio) is ≤ 1.5. Low-dose aspirin is permitted (80-100 mg daily).

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • National Cancer Center, Korea

    Goyang-si, Gyeonggi-do

Other trials in South Korea

About this study

Official title: A Randomized Phase II Study of Sorafenib Maintenance in Patients With Extensive Disease Small Cell Lung Cancer (ED-SCLC) After Response to Induction Chemotherapy

A Phase I trial of weekly topotecan in combination with sorafenib in treatment of relapsed Small cell lung cancer (SCLC) has been commenced. In the present randomized phase 2 study, the investigators will research whether Sorafenib maintenance prolongs progression free survival (PFS) and overall survival (OS) in patients with ED-SCLC who achieved CR or PR after platinum-based induction chemotherapy.

Read the detailed description

Small cell lung cancer (SCLC) comprises 10-15 % of all lung cancer. Despite high responsiveness to initial chemotherapy, its high relapse rate makes the treatment of SCLC is challenging. With platinum plus etoposide or irinotecan, overall response rate is as high as 85%, however, the median duration of response is short (approximately 4 months), and median survival times are 9 to 11 months, with a 2-year survival rate of less than 10% [J Clin oncology. 2009 Oct 1;27(28):4787-92]. New and more effective agents are clearly needed against SCLC. Sorafenib is a multikinase inhibitors acting on pathways involved in tumour progression and angiogenesis, and is undergoing investigation for the treatment of SCLC in either the first- or second-line setting. The only data available so far are on sorafenib, which seems to be a promising agent with a median survival of 7 and 5 months in platinum-sensitive and platinum-refractory patients, respectively (2008 J Clin oncology 26. Abstract 8039). This compared favourably with historical controls receiving salvage chemotherapy.

Being tested
Sorafenib
Keywords
Sorafenib (nexavar), ED-SCLC, Maintenance, Extensive Disease Small cell lung cancer
Medical subject headings
Small Cell Lung Carcinoma

What participants receive

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

  • SorafenibDrug

    Also called Nexavar

    Sorafenib 400mg, bid(800mg/day), daily, PO

Study groups in NCT01159327
Study groupRoleWhat they receive
Arm AExperimentalSorafenib maintenance arm
Receives: Drug: Sorafenib
Arm BNo interventionobservation arm

What is being measured

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

  1. Progression-free survival

    Progression-free survival was calculated from the randomization date until evidence of PD or death

    Measured: every 8 weeks

Secondary outcomes (2)

  1. Overall survival

    The duration of overall survival is measured from randomization date to the date of death from any cause or the last follow-up examination

    Measured: the date of registration to the date of death

  2. Toxicity

    For grading of adverse events CTCAE criteria (version 4.0) will be utilized. All adverse events occurring between first drug intake until 30 days after last treatment administration will be reported.

    Measured: First drug intake until 30 days after last treatment admisitration

Timeline

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

  1. First posted9 Jul 2010 (estimated)
  2. Study startDec 2010
  3. Primary completionApr 2013
  4. Study completionJun 2013

Why it stopped: low enrolling participants

Resources

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
13 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01159327
Sponsor's protocol ID
NCCCTS-10-476
Status last verified
Nov 2015
First submitted
8 Jul 2010
Last updated
11 Nov 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sorafenib in people with Small Cell Lung Cancer, run by National Cancer Center, Korea at 1 site in South Korea.

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

Who may be eligible to take part?

The sponsor lists 11 inclusion and 25 exclusion criteria. 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 11 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. 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?

The study was stopped early (reason given: low enrolling participants). Results are not available in the source record.

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 (time frame: every 8 weeks). 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 NCT01159327.

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 11 Nov 2015.

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