Vinorelbine and Ifosfamide as Third-line Treatment for Refractory Small Cell Lung Cancer

• Status: Unknown status
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Although fist-line therapy with Cisplatin and etoposide(EP)or Carboplatin and etoposide(CE)and second-line therapy with topotecan has been given, patients with ED-SCLC still relapse and 2-year survival is less than 10%. There is no standard treatment recommendation for this group of patients who failed to second-line therapy and had good performance status. Some cytotoxic drugs for the treatment of non-small cell lung cancer, i.e. vinorelbine, paclitaxel, and ifosfamide, were used in refractory or recurrent SCLC patients. Recently, a retrospective study showed the overall response rate was 30%, the median progression free survival (PFS) was 6.5 months, and the median overall survival was 10.4 months in advanced combined SCLC patients treated with first-line regimen of vinorelbine, ifosfamide and cisplatin (NIP). Because of the previous platinum administration and patient's performance status, only vinorelbine and ifosfamide (NI) are combined and used as third-line therapy for refractor or recurrent ED-SCLC in our lung cancer center. And this clinical trial is designed to prospectively investigate the efficacy and safety of NI regimen in refractory or recurrent ED-SCLC patients in our center.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking Union Medical College Hospital
• Treatments: Ifosfamide; Isophosphamide mustard; Mesna; Vinblastine; Vinorelbine

Criteria

Inclusion Criteria:

• histologically or cytologically confirmed ED-SCLC;

• age>18 and <75;

• measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST);

• previous treatments including first-line therapy with EP or CE and second-line therapy with topotecan;

• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2;

• life expectancy > 3 months;

• neutrophil count > 1500/ul;

• platelet count > 100,000ul;

• hemoglobin level > 9g/dl;

• bilirubin level < 1.5mg/dL;

• creatinine level < 2mg/dl;

• alanine transaminase (AST) levels < 2.5× upper limit of normal (ULN)(or < 5× ULN if liver metastases were present);

Exclusion Criteria:

• previous anticancer therapy including vinorelbine or ifosfamide;

• newly diagnosed central nervous system (CNS) metastasis and not treated by radiotherapy or surgery;

• additional malignancies;

• uncontrolled systemic disease;

• pregnancy or breast feeding phase;