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

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: NCT01752517
Recruitment Status : Unknown
Verified December 2012 by Peking Union Medical College Hospital.
Recruitment status was:  Recruiting
First Posted : December 19, 2012
Last Update Posted : December 19, 2012
Information provided by (Responsible Party):
Peking Union Medical College Hospital

Brief 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.

Condition or disease Intervention/treatment
Small Cell Lung Cancer Drug: NI group

Detailed Description:

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 again.

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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
Study Start Date : December 2012
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : December 2015

Group/Cohort Intervention/treatment
refractory SCLC
NI group vinorelbine 25mg/m2 d1,d8; Ifosfamide 1.25g/m2 d1-d3; Mesna 400mg iv 0,4,8 hours after ifosfamide administration for 3 days; every 3 weeks; up to the maximum cycles (total:6);
Drug: NI group
vinorelbine 25mg/m2 d1,d8; ifosfamide 1.25g/m2 d1-d3; Mesna 400mg iv 0,4,8 hours after ifosfamide administration for 3 days
Other Names:
  • vinorelbine;
  • ifosfamide;
  • Mesna;

Primary Outcome Measures :
  1. the disease control rate [ Time Frame: up to 9 weeks ]
    The disease control rate includes the rate of progression disease,partial remission and stable disease.

Secondary Outcome Measures :
  1. progression free survival [ Time Frame: up to 52 weeks (about one year) ]
    From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 52 weeks.

  2. Overall survival [ Time Frame: Up to 100 weeks ]
    From date of randomization until the date of death from any cause, assessed up to 100 weeks.

  3. the score of functional assessment of cancer treatment-lung (FACT-L) [ Time Frame: up to 52 weeks ]
    FACT-L ia assessed at different time points. (Date of randomization, 1 weeks after chemotherapy, every cycle of chemotherapy, every month after chemotherapy,up to 52 weeks)

  4. Number of participants with adverse events [ Time Frame: Up to six months ]
    The adverse events are assessed by National Cancer Institute-Common Toxicity Criteria (Version 3.0)(NCI-CTC).

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
ED-SCLC patients who relapse after treatment with first-line EP or CE and second-line topotecan.

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;

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): NCT01752517

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Contact: Mengzhao Wang, MD 010-69155039 ext +86
Contact: Jing Zhao, MD 010-69158206 ext +86

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China, Beijing
Department of Respiratory Medicine, Peking Union Medical College Hospital Recruiting
Beijing, Beijing, China, 100730
Contact: Mengzhao Wang, MD    010-69155039 ext +86   
Contact: Jing Zhao, MD    010-69158206 ext +86   
Sub-Investigator: Wei Zhong, MD         
Sub-Investigator: Jinmei Luo, MD         
Sponsors and Collaborators
Peking Union Medical College Hospital
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Principal Investigator: Mengzhao Wang, MD Peking Union Medical College Hospital

Publications of Results:

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Responsible Party: Peking Union Medical College Hospital Identifier: NCT01752517     History of Changes
Other Study ID Numbers: PUMCH-S463
First Posted: December 19, 2012    Key Record Dates
Last Update Posted: December 19, 2012
Last Verified: December 2012

Keywords provided by Peking Union Medical College Hospital:
small cell lung cancer
third-line treatment

Additional relevant MeSH terms:
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Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Isophosphamide mustard
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Alkylating
Alkylating Agents
Protective Agents
Physiological Effects of Drugs