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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01159327
Recruitment Status : Terminated (low enrolling participants)
First Posted : July 9, 2010
Last Update Posted : November 11, 2015
Information provided by (Responsible Party):
Ji-youn Han, National Cancer Center, Korea

Brief 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 patients with ED-SCLC who achieved CR or PR after platinum-based induction chemotherapy.

Condition or disease Intervention/treatment Phase
Small Cell Lung Cancer Drug: Sorafenib Phase 2

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  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : December 2010
Actual Primary Completion Date : April 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: Arm A
Sorafenib maintenance arm
Drug: Sorafenib
Sorafenib 400mg, bid(800mg/day), daily, PO
Other Name: Nexavar

No Intervention: Arm B
observation arm

Primary Outcome Measures :
  1. Progression-free survival [ Time Frame: every 8 weeks ]
    Progression-free survival was calculated from the randomization date until evidence of PD or death

Secondary Outcome Measures :
  1. 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

  2. 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.

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Ages Eligible for Study:   18 Months and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01159327

Korea, Republic of
National Cancer Center, Korea
Goyang-si, Gyeonggi-do, Korea, Republic of
Sponsors and Collaborators
National Cancer Center, Korea
Principal Investigator: JI-YOUN HAN, PhD.MD National Cancer Center

Responsible Party: Ji-youn Han, Head, Center for Lung Cancer, National Cancer Center, Korea Identifier: NCT01159327     History of Changes
Other Study ID Numbers: NCCCTS-10-476
First Posted: July 9, 2010    Key Record Dates
Last Update Posted: November 11, 2015
Last Verified: November 2015

Keywords provided by Ji-youn Han, National Cancer Center, Korea:
Sorafenib (nexavar)
Extensive Disease Small cell lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vitamin B Complex
Growth Substances
Physiological Effects of Drugs