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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by National Cancer Center, Korea.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Ji-youn Han, National Cancer Center, Korea
ClinicalTrials.gov Identifier:
NCT01159327
First received: July 8, 2010
Last updated: September 15, 2011
Last verified: September 2011
  Purpose

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 Intervention Phase
Small Cell Lung Cancer
Drug: Sorafenib
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by National Cancer Center, Korea:

Primary Outcome Measures:
  • Progression-free survival [ Time Frame: every 8 weeks ] [ Designated as safety issue: No ]
    Progression-free survival was calculated from the randomization date until evidence of PD or death


Secondary Outcome Measures:
  • Overall survival [ Time Frame: the date of registration to the date of death ] [ Designated as safety issue: No ]
    The duration of overall survival is measured from randomization date to the date of death from any cause or the last follow-up examination

  • Toxicity [ Time Frame: First drug intake until 30 days after last treatment admisitration ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 120
Study Start Date: December 2010
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A
Sorafenib maintenance arm
Drug: Sorafenib
Sorafenib 400mg, bid(800mg/day), daily, PO
Other Name: Nexavar
No Intervention: Arm B
observation arm

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.

  Eligibility

Ages Eligible for Study:   18 Months and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01159327

Contacts
Contact: Sung JIn Yoon, RN +82-31-920-0405 jinijiniya@ncc.re.kr

Locations
Korea, Republic of
National Cancer Center, Korea Recruiting
Goyang-si, Gyeonggi-do, Korea, Republic of
Contact: Joung Hee Han, RN    +82-31-920-0409    hanjonghee@ncc.re.kr   
Sub-Investigator: Jin Soo Lee, M.D.         
Sub-Investigator: Heung Tae Kim, M.D.         
Principal Investigator: Ji-Youn Han, M.D.         
Sub-Investigator: Tak Yun, M.D.         
Sponsors and Collaborators
National Cancer Center, Korea
Bayer
Investigators
Principal Investigator: JI-YOUN HAN, PhD.MD National Cancer Center
  More Information

No publications provided

Responsible Party: Ji-youn Han, Head, Center for Lung Cancer, National Cancer Center, Korea
ClinicalTrials.gov Identifier: NCT01159327     History of Changes
Other Study ID Numbers: NCCCTS-10-476
Study First Received: July 8, 2010
Last Updated: September 15, 2011
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by National Cancer Center, Korea:
Sorafenib (nexavar)
ED-SCLC
Maintenance
Extensive Disease Small cell lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Sorafenib
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014