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

NCT01752517 | Unknown

• 1 other identifier: PUMCH-S463
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Small Cell Lung Cancer

Keywords

small cell lung cancer; chemotherapy; vinorelbine; ifosfamide; third-line treatment

Outcome Measures

Primary Outcomes (1)

• the disease control rate

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

  up to 9 weeks

Secondary Outcomes (4)

• progression free survival

  up to 52 weeks (about one year)

• Overall survival

  Up to 100 weeks

• the score of functional assessment of cancer treatment-lung (FACT-L)

  up to 52 weeks

• Number of participants with adverse events

  Up to six months

Study Arms (1)

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

Interventions

NI group DRUG

vinorelbine 25mg/m2 d1,d8; ifosfamide 1.25g/m2 d1-d3; Mesna 400mg iv 0,4,8 hours after ifosfamide administration for 3 days

Also known as: vinorelbine;, ifosfamide;, Mesna;

refractory SCLC

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

ED-SCLC patients who relapse after treatment with first-line EP or CE and second-line topotecan.

You may qualify if:

• 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);

You may not qualify if:

• 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;

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Department of Respiratory Medicine, Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

Related Publications (9)

• Jackman DM, Johnson BE. Small-cell lung cancer. Lancet. 2005 Oct 15-21;366(9494):1385-96. doi: 10.1016/S0140-6736(05)67569-1.

  PMID: 16226617 RESULT

• Simon GR, Turrisi A; American College of Chest Physicians. Management of small cell lung cancer: ACCP evidence-based clinical practice guidelines (2nd edition). Chest. 2007 Sep;132(3 Suppl):324S-339S. doi: 10.1378/chest.07-1385.

  PMID: 17873178 RESULT

• Clark R, Ihde DC. Small-cell lung cancer: treatment progress and prospects. Oncology (Williston Park). 1998 May;12(5):647-58; discussion 661-3.

  PMID: 9597676 RESULT

• Fukuoka M, Furuse K, Saijo N, Nishiwaki Y, Ikegami H, Tamura T, Shimoyama M, Suemasu K. Randomized trial of cyclophosphamide, doxorubicin, and vincristine versus cisplatin and etoposide versus alternation of these regimens in small-cell lung cancer. J Natl Cancer Inst. 1991 Jun 19;83(12):855-61. doi: 10.1093/jnci/83.12.855.

  PMID: 1648142 RESULT

• Wolf M, Havemann K, Holle R, Gropp C, Drings P, Hans K, Schroeder M, Heim M, Dommes M, Mende S, et al. Cisplatin/etoposide versus ifosfamide/etoposide combination chemotherapy in small-cell lung cancer: a multicenter German randomized trial. J Clin Oncol. 1987 Dec;5(12):1880-9. doi: 10.1200/JCO.1987.5.12.1880.

  PMID: 2824710 RESULT

• Roth BJ, Johnson DH, Einhorn LH, Schacter LP, Cherng NC, Cohen HJ, Crawford J, Randolph JA, Goodlow JL, Broun GO, et al. Randomized study of cyclophosphamide, doxorubicin, and vincristine versus etoposide and cisplatin versus alternation of these two regimens in extensive small-cell lung cancer: a phase III trial of the Southeastern Cancer Study Group. J Clin Oncol. 1992 Feb;10(2):282-91. doi: 10.1200/JCO.1992.10.2.282.

  PMID: 1310103 RESULT

• Skarlos DV, Samantas E, Kosmidis P, Fountzilas G, Angelidou M, Palamidas P, Mylonakis N, Provata A, Papadakis E, Klouvas G, et al. Randomized comparison of etoposide-cisplatin vs. etoposide-carboplatin and irradiation in small-cell lung cancer. A Hellenic Co-operative Oncology Group study. Ann Oncol. 1994 Sep;5(7):601-7. doi: 10.1093/oxfordjournals.annonc.a058931.

  PMID: 7993835 RESULT

• von Pawel J, Schiller JH, Shepherd FA, Fields SZ, Kleisbauer JP, Chrysson NG, Stewart DJ, Clark PI, Palmer MC, Depierre A, Carmichael J, Krebs JB, Ross G, Lane SR, Gralla R. Topotecan versus cyclophosphamide, doxorubicin, and vincristine for the treatment of recurrent small-cell lung cancer. J Clin Oncol. 1999 Feb;17(2):658-67. doi: 10.1200/JCO.1999.17.2.658.

  PMID: 10080612 RESULT

• Luo J, Wu FY, Li AW, Zheng D, Liu JM. Comparison of vinorelbine, ifosfamide and cisplatin (NIP) and etoposide and cisplatin (EP) for treatment of advanced combined small cell lung cancer (cSCLC) patients: a retrospective study. Asian Pac J Cancer Prev. 2012;13(9):4703-6. doi: 10.7314/apjcp.2012.13.9.4703.

  PMID: 23167406 RESULT

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

Vinorelbine; Ifosfamide; Mesna

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)

Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Cyclophosphamide; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Oxazines; Heterocyclic Compounds, 1-Ring; Alkanesulfonates; Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Sulfhydryl Compounds; Sulfur Compounds; Sulfonic Acids; Sulfur Acids

Study Officials

• Mengzhao Wang, MD

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mengzhao Wang, MD

CONTACT

010-69155039; mengzhaowang@sina.com

Jing Zhao, MD

CONTACT

010-69158206; pumchzj@sina.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2012
• First Posted: December 19, 2012
• Study Start: December 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2015
• Last Updated: December 19, 2012

Record last verified: 2012-12

Locations

CN (1)