Maintenance Gemcitabine in the Chinese Advanced Lung Cancer

NCT01336192 | Unknown Phase 4

• 1 other identifier: SHPH-11ZL113
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

Lung cancer, the most common cancer worldwide, remains the leading cause of cancer death. Approximately two-thirds of all patients with newly diagnosed non-small-cell lung cancer (NSCLC) present with advanced stage that palliative chemotherapy is the only appropriate measure. The standard treatment for this patient population consists of third generation platinum-based doublet regimen for no more than 6 cycles followed by watch and wait until disease progression (PD) before the administration of second-line and third-line systemic anticancer therapeutic agents. Patients who go on to receive second-line therapy represent a selected subgroup with an improved overall prognosis. Switch maintenance therapy with pemetrexed or erlotinib in patients with advanced NSCLC without PD after first-line chemotherapy has been confirmed to improve progression free survival (PFS) and overall survival (OS) significantly compared with placebo in two large randomized controlled studies. However, continuation gemcitabine maintenance therapy in this setting yields conflicting results in the west, i.e.showing a prolongation of PFS without OS improvement. Thus, we investigate the efficacy and safety of continuation of gemcitabine maintenance therapy for patients with metastatic NSCLC with ECOG performance status of 0-1 and without PD after four cycles of first-line chemotherapy with gemcitabine and cisplatin in China.

Conditions

Non Small Cell Lung Cancer

Keywords

Advanced NSCLC; Maintenance therapy; Gemcitabine

Outcome Measures

Primary Outcomes (1)

• Progression free survival

  From the start of maintenance therapy or Best Suppotive Care(BSC) until the date of documented progressive disease or death from any cause

  12 months

Secondary Outcomes (5)

• Overall Survival

  18 months

• Response Rate

  approximately 4 weeks

• Time to The Progression

  18 months

• Health Related Quality of Life

  Approximately 4 weeks

• Number of Participants with treatment-related grade III/IV adverse events

  6 months

Study Arms (2)

Best supportive care

NO INTERVENTION

Best supportive care

Maintenance gemcitabine

EXPERIMENTAL

Maintenance therapy of gemcitabine alone

Drug: Gemcitabine; Drug: Best supportive care

Interventions

Gemcitabine DRUG

Gemcitabine 1250mg/m\^2 Day 1 and 8, 28 days per cycle until PD

Maintenance gemcitabine

Best supportive care DRUG

Best supportive care

Maintenance gemcitabine

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologic or cytologic confirmed diagnosis of Stage IV NSCLC according to 2009 the seventh edition of TNM staging of lung tumors.
• No disease progression after four cycles of first-line chemotherapy with gemcitabine plus cisplatin (running period) within one month before the enrollment.
• Brain metastases are permitted if treated with full course of whole brain radiotherapy without the presence of symptomatic central nervous system metastases.
• ECOG score 0-1

You may not qualify if:

• First-line chemotherapy other than combination treatment of gemcitabine plus cisplatin
• Other therapy including targeted therapy, immunotherapy and prior radiotherapy for the treatment of the primary tumor prior to enrollment.
• Active infection
• Inadequate liver and renal function.
• Serious concomitant systemic disorder incompatible with the study.
• Second primary malignancy (except in situ carcinoma of the cervix, adequately treated basal cell carcinoma of the skin, T1 vocal cord cancer in remission, or prior malignancy treated more than 5 years prior enrollment without recurrence)
• Presence of the pregnancy

Sponsors & Collaborators

• Tongji University: lead
• Shanghai Pulmonary Hospital, Shanghai, China: collaborator

Study Sites (1)

Shanghai Pulmonary Hospital Medical Oncology Department

Shanghai, Shanghai Municipality, 200433, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Gemcitabine

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)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Di Zheng, MD

  Shanghai Pulmonary Hospital, Shanghai, China

  PRINCIPAL INVESTIGATOR

• Wen Gao, MD

  Shanghai Pulmonary Hospital, Shanghai, China

  STUDY CHAIR

• Jianfang Xu, MD

  Shanghai Pulmonary Hosptial

  STUDY DIRECTOR

• Li Wang, MD

  Shanghai Pulmonary Hospital, Shanghai, China

  STUDY DIRECTOR

• Meijun Lv, MD

  Shanghai Pulmonary Hospital, Shanghai, China

  STUDY DIRECTOR

• Jian Ni, MD

  Shanghai Pulmonary Hospital, Shanghai, China

  STUDY DIRECTOR

• Jie Zhang, MD

  Shanghai Pulmonary Hospital, Shanghai, China

  STUDY DIRECTOR

• Bing Lu, MD

  Shanghai Pulmonary Hospital, Shanghai, China

  STUDY DIRECTOR

• Ying Xu, MD

  Shanghai Pulmonary Hospital, Shanghai, China

  STUDY DIRECTOR

Central Study Contacts

Haiping Zhang, MD

CONTACT

86-21-65115006; zhp7341@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 7, 2011
• First Posted: April 15, 2011
• Study Start: April 1, 2011
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2013
• Last Updated: April 15, 2011

Record last verified: 2011-04

Locations

CN (1)