Maintenance Gemcitabine in the Chinese Advanced Lung Cancer (MAGICAL)

• ClinicalTrials.gov Identifier: NCT01336192
• Recruitment Status: Unknown
• First Posted: April 15, 2011
• Last Update Posted: April 15, 2011
• Sponsor: Tongji University
• Collaborator: Shanghai Pulmonary Hospital, Shanghai, China
• Information provided by: Tongji University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Non Small Cell Lung Cancer	Drug: Gemcitabine; Drug: Best supportive care	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 240 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Maintenance Gemcitabine or Best Supportive Care for the Chinese Advanced NSCLC Patients Without Progression Disease After Given Four Cycles of the Induction Chemotherapy With Gemcitabine Plus Cisplatin
• Study Start Date: April 2011
• Estimated Primary Completion Date: April 2012
• Estimated Study Completion Date: April 2013

Arms and Interventions

Arm	Intervention/treatment
No Intervention: Best supportive care; Best supportive care
Experimental: Maintenance gemcitabine; Maintenance therapy of gemcitabine alone	Drug: Gemcitabine; Gemcitabine 1250mg/m^2 Day 1 and 8, 28 days per cycle until PD; Drug: Best supportive care; Best supportive care

Outcome Measures

Primary Outcome Measures :

1. Progression free survival [ Time Frame: 12 months ]
   From the start of maintenance therapy or Best Suppotive Care(BSC) until the date of documented progressive disease or death from any cause

Secondary Outcome Measures :

1. Overall Survival [ Time Frame: 18 months ]
   From the start of maintenance therapy or BSC until the date of documented death from any cause
2. Response Rate [ Time Frame: approximately 4 weeks ]
   From the start of maintenance therapy or BSC until the date of documented progressive disease
3. Time to The Progression [ Time Frame: 18 months ]
   From the start of maintenance therapy or BSC until the date of documented progressive disease
4. Health Related Quality of Life [ Time Frame: Approximately 4 weeks ]
   From the start of maintenance therapy or BSC until the date of documented progressive disease or the termination of study
5. Number of Participants with treatment-related grade III/IV adverse events [ Time Frame: 6 months ]
   frequency and severity of adverse events and laboratory abnormalities

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Contacts and Locations

Contacts

Contact: Haiping Zhang, MD; 86-21-65115006 ext 3068; zhp7341@hotmail.com

Locations

China, Shanghai

Shanghai Pulmonary Hospital Medical Oncology Department; Recruiting

Shanghai, Shanghai, China, 200433

Contact: Ying Xu, MD 86-21-65115006 ext 1053 xuying2186@hotmail.com

Principal Investigator: Di Zheng, MD

Sponsors and Collaborators

Tongji University

Shanghai Pulmonary Hospital, Shanghai, China

Investigators

• Principal Investigator: Di Zheng, MD; Shanghai Pulmonary Hospital, Shanghai, China
• Study Chair: Wen Gao, MD; Shanghai Pulmonary Hospital, Shanghai, China
• Study Director: 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

More Information

• Responsible Party: Di Zheng/MD, Shanghai Pulmonary Hospital
• ClinicalTrials.gov Identifier: NCT01336192
• Other Study ID Numbers: SHPH-11ZL113
• First Posted: April 15, 2011
• Last Update Posted: April 15, 2011
• Last Verified: April 2011

Keywords provided by Tongji University:

Advanced NSCLC; Maintenance therapy; Gemcitabine

Additional relevant MeSH terms:

Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Gemcitabine; Antimetabolites, Antineoplastic; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Antiviral Agents; Anti-Infective Agents; Enzyme Inhibitors; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs