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A Phase Ⅱ Single-arm Clinical Trial to Investigate the Efficacy and Safety of Vinorelbine-ifosfamide Regimen as Third-line Treatment in Refractory or Recurrent Extensive Small Cell Lung Cancer Patients

18 Years
75 Years
Open (Enrolling)
Small Cell Lung Cancer

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Trial Information

A Phase Ⅱ Single-arm Clinical Trial to Investigate the Efficacy and Safety of Vinorelbine-ifosfamide Regimen as Third-line Treatment in Refractory or Recurrent Extensive Small Cell Lung Cancer Patients

Small cell lung cancer (SCLC) is a highly aggressive disease characterized by its rapid
doubling time, high growth fraction, early development of disseminated disease, and dramatic
response to first-line chemotherapy and radiation. Small cell lung cancer accounts for
approximately 20%-25% lung cancer patients. SCLC patients are categorized as limited
disease, defined as disease that is confined to the ipsilateral hemithorax that can be
encompassed within a tolerable radiation port, or extensive disease (ED), defined as the
presence of overt metastatic disease determined by imaging or physical examination. Two
third of patients are diagnosed with ED at presentation. Despite the development of novel
cytotoxic drugs, the therapeutic approach to SCLC has been stagnant for more than twenty
years. Standard treatment for ED-SCLC remains EP or CE, a regimen that yield a median
survival of approximately 9 months and a 5-year survival of less than 1%.

Most patients are destined to relapse, and the prognosis for this group of patients who
relapse is poor. Patients who relapse < 3 months after first-line therapy are commonly
called refractory, and patients who relapse 3 months after therapy are labeled as sensitive.
In a randomized multicenter study, von Pawel et al compared cyclophosphamide, adriamycin,
and vincristine (CAV) with topotecan as a single agent in patients who had relapse at least
60 days (2 months) after initial therapy. The response rates were 24.3% in patients treated
with topotecan and 18.3% in patients treated with CAV (P=0.285). Median times to progression
were 13.3 weeks for the topotecan arm and 12.3 weeks for the CAV arm. Median survival times
were 25 weeks for topotecan and 24.7 weeks for CAV. The proportion of patients with symptom
improvement was greater in the topotecan arm than in the CAV arm. The authors concluded
that topotecan was at least as effective as CAV in the treatment of patients with recurrent
SCLC. So in some guidelines for SCLC, topotecan is recommended as the standard second-line
treatment in patients who relapse less than 3 months. As for patients who relapse more than
six months after the end of initial treatment, EP or CE regimen is recommended to be used

Inclusion Criteria:

- histologically or cytologically confirmed ED-SCLC;

- age>18 and <75;

- measurable disease as defined by Response Evaluation Criteria in Solid Tumors

- 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;

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

the disease control rate

Outcome Description:

The disease control rate includes the rate of progression disease,partial remission and stable disease.

Outcome Time Frame:

up to 9 weeks

Safety Issue:


Principal Investigator

Mengzhao Wang, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Peking Union Medical College Hospital


China: Food and Drug Administration

Study ID:




Start Date:

December 2012

Completion Date:

December 2015

Related Keywords:

  • Small Cell Lung Cancer
  • small cell lung cancer
  • chemotherapy
  • vinorelbine
  • ifosfamide
  • third-line treatment
  • Lung Neoplasms
  • Small Cell Lung Carcinoma