- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01159327
Study of Sorafenib Maintenance in Patients With ED-SCLC After Response to Induction Chemotherapy
November 9, 2015 updated by: Ji-youn Han, National Cancer Center, Korea
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.
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
13
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Gyeonggi-do
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Goyang-si, Gyeonggi-do, Korea, Republic of
- National Cancer Center, Korea
-
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion criteria:
- 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.
- 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
Exclusion Criteria:
- 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
- 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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm A
Sorafenib maintenance arm
|
Sorafenib 400mg, bid(800mg/day), daily, PO
Other Names:
|
No Intervention: Arm B
observation arm
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression-free survival
Time Frame: every 8 weeks
|
Progression-free survival was calculated from the randomization date until evidence of PD or death
|
every 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall survival
Time Frame: the date of registration to the date of death
|
The duration of overall survival is measured from randomization date to the date of death from any cause or the last follow-up examination
|
the date of registration to the date of death
|
Toxicity
Time Frame: First drug intake until 30 days after last treatment admisitration
|
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.
|
First drug intake until 30 days after last treatment admisitration
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: JI-YOUN HAN, PhD.MD, National Cancer Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2010
Primary Completion (Actual)
April 1, 2013
Study Completion (Actual)
June 1, 2013
Study Registration Dates
First Submitted
July 8, 2010
First Submitted That Met QC Criteria
July 8, 2010
First Posted (Estimate)
July 9, 2010
Study Record Updates
Last Update Posted (Estimate)
November 11, 2015
Last Update Submitted That Met QC Criteria
November 9, 2015
Last Verified
November 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Small Cell Lung Carcinoma
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Protein Kinase Inhibitors
- Sorafenib
Other Study ID Numbers
- NCCCTS-10-476
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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