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

NCT01159327 | Terminated Phase 2

• 1 other identifier: NCCCTS-10-476
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Small Cell Lung Cancer

Keywords

Sorafenib (nexavar); ED-SCLC; Maintenance; Extensive Disease Small cell lung cancer

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

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

  every 8 weeks

Secondary Outcomes (2)

• Overall survival

  the date of registration to the date of death

• Toxicity

  First drug intake until 30 days after last treatment admisitration

Study Arms (2)

Arm A

EXPERIMENTAL

Sorafenib maintenance arm

Drug: Sorafenib

Arm B

NO INTERVENTION

observation arm

Interventions

Sorafenib DRUG

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

Also known as: Nexavar

Arm A

Eligibility Criteria

• Age: 18 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cancer Center, Korea: lead
• Bayer: collaborator

Study Sites (1)

National Cancer Center, Korea

Goyang-si, Gyeonggi-do, South Korea

Location

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

Sorafenib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• JI-YOUN HAN, PhD.MD

  National Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head, Center for Lung Cancer

Study Record Dates

• First Submitted: July 8, 2010
• First Posted: July 9, 2010
• Study Start: December 1, 2010
• Primary Completion: April 1, 2013
• Study Completion: June 1, 2013
• Last Updated: November 11, 2015

Record last verified: 2015-11

Locations

KR (1)