AP/GP: Pemetrexed Plus Cisplatin Versus Gemcitabine Plus Cisplatin for Advanced NSCLC Metastatic Non-small Cell Lung Cancer

• Sponsor: Sun Yat-sen University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01194453
• Collaborator: (none)
• Enrollment: 288
• Location: 1
• Arms: 2
• Duration (Months): 33
• Patients Per Site Per Month: 8.7

Study Details

Study Description

Brief Summary

A phase III trial has demonstrated that in advanced non-small cell lung cancer (NSCLC) cisplatin/ pemetrexed provides similar efficacy with better tolerability and more convenient administration than cisplatin/gemcitabine. Moreover,this trial showed survival differences based on histologic type. The investigators want to research some biomarkers that can predict clinical outcomes.

Condition or Disease	Intervention/Treatment	Phase
Non-small Cell Lung Cancer; Efficacy	Drug: cisplatin, dexamethasone,vitamin B12, folic acid; Drug: cisplatin, gemcitabine	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 288 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase 2,Open-label Study of First Line Pemetrexed Plus Cisplatin Versus Gemcitabine Plus Cisplatin for Advanced and Metastatic Non Small Cell Lung Cancer and Biomarker Study
• Study Start Date: Nov 1, 2009
• Actual Primary Completion Date: Sep 1, 2010
• Actual Study Completion Date: Aug 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group A	Drug: cisplatin, dexamethasone,vitamin B12, folic acid; Patients received cisplatin 75mg/m2 plus pemetrexed 500 mg/m2 on day 1.Chemotherapy was repeated every 3 weeks for a maximum of six cycles.Patients received dexamethasone prophylaxis of 3.75mg orally twice per day on the day before, the day of, and the day after each day-1 treatment. patients received oral folic acid (1,000ug)daily and a vitamin B12 injection (1,000 ug) every 9 weeks, beginning 1 to 2 weeks before the first dose and continuing until 3 weeks after the last dose of study treatment
Active Comparator: Group B	Drug: cisplatin, gemcitabine; cisplatin 75mg/m2 on day 1 plus gemcitabine 1000 mg/m2 on days 1 and 8

Outcome Measures

Primary Outcome Measures

1. Progression Free Survival (PFS) [36months]

Secondary Outcome Measures

1. Response Rate [6 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Chemotherapy-naive patients with histologically or cytologically confirmed adenocarcinoma and large-cell carcinoma, classified as stage IIIB not amenable to curative treatment or stage IV

2. With at least one unidimensionally measurable lesion according to the Response Evaluation Criteria in Solid Tumors;

3. with an Eastern CooperativeOncology Group performance status of 0 or 1,

4. At least 18 years of age

5. adequate bone marrow reserve and organ function including calculated creatinine clearance 45 mL/min based on the standard Cockcroft and Gault formula.

6. Prior radiation therapy was permitted if it was completed at least 4 weeks before study treatment

7. patients had fully recovered from its acute effects.

Exclusion Criteria:

1. peripheral neuropathy > National Cancer Institute Common Toxicity Criteria grade 1

2. progressive brain metastases,

3. uncontrolled third-space fluid retention before study entry.

4. Patients unable to interrupt aspirin and other nonsteroidal anti-inflammatory drugs or if they were unable or unwilling to take folic acid, vitamin B12, or corticosteroids.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cancer Center of Sun Yat-Sen University (CCSU)	Guangzhou	Guangdong	China

Sponsors and Collaborators

• Sun Yat-sen University

Investigators

• Study Chair: Li Zhang, MD, Cancer Center of Sun Yat-Sen University (CCSU)

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Li Zhang, Professor, Sun Yat-sen University
• ClinicalTrials.gov Identifier: NCT01194453
• Other Study ID Numbers: HANSOH20090601
• First Posted: Sep 3, 2010
• Last Update Posted: Jun 16, 2016
• Last Verified: May 1, 2016

• Additional relevant MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Folic Acid; Vitamin B 12; Hydroxocobalamin; Gemcitabine; Dexamethasone; Cisplatin

Study Results

Participant Flow

Arm/Group Title	Group A	Group B
Arm/Group Description	cisplatin, dexamethasone,vitamin B12, folic acid: Patients received cisplatin 75mg/m2 plus pemetrexed 500 mg/m2 on day 1.Chemotherapy was repeated every 3 weeks for a maximum of six cycles.Patients received dexamethasone prophylaxis of 3.75mg orally twice per day on the day before, the day of, and the day after each day-1 treatment. patients received oral folic acid (1,000ug)daily and a vitamin B12 injection (1,000 ug) every 9 weeks, beginning 1 to 2 weeks before the first dose and continuing until 3 weeks after the last dose of study treatment	cisplatin, gemcitabine: cisplatin 75mg/m2 on day 1 plus gemcitabine 1000 mg/m2 on days 1 and 8
Period Title: Overall Study
STARTED	144	144
COMPLETED	127	127
NOT COMPLETED	17	17

Baseline Characteristics

Arm/Group Title	Group A	Group B	Total
Arm/Group Description	cisplatin, dexamethasone,vitamin B12, folic acid: Patients received cisplatin 75mg/m2 plus pemetrexed 500 mg/m2 on day 1.Chemotherapy was repeated every 3 weeks for a maximum of six cycles.Patients received dexamethasone prophylaxis of 3.75mg orally twice per day on the day before, the day of, and the day after each day-1 treatment. patients received oral folic acid (1,000ug)daily and a vitamin B12 injection (1,000 ug) every 9 weeks, beginning 1 to 2 weeks before the first dose and continuing until 3 weeks after the last dose of study treatment	cisplatin, gemcitabine: cisplatin 75mg/m2 on day 1 plus gemcitabine 1000 mg/m2 on days 1 and 8	Total of all reporting groups
Overall Participants	144	144	288
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	129 89.6%	120 83.3%	249 86.5%
>=65 years	15 10.4%	24 16.7%	39 13.5%
Sex: Female, Male (Count of Participants)
Female	60 41.7%	73 50.7%	133 46.2%
Male	84 58.3%	71 49.3%	155 53.8%
Region of Enrollment (participants) [Number]
China	144 100%	144 100%	288 100%

Outcome Measures

1. Primary Outcome

Title	Progression Free Survival (PFS)
Time Frame	36months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group A	Group B
Arm/Group Description	cisplatin, dexamethasone,vitamin B12, folic acid: Patients received cisplatin 75mg/m2 plus pemetrexed 500 mg/m2 on day 1.Chemotherapy was repeated every 3 weeks for a maximum of six cycles.Patients received dexamethasone prophylaxis of 3.75mg orally twice per day on the day before, the day of, and the day after each day-1 treatment. patients received oral folic acid (1,000ug)daily and a vitamin B12 injection (1,000 ug) every 9 weeks, beginning 1 to 2 weeks before the first dose and continuing until 3 weeks after the last dose of study treatment	cisplatin, gemcitabine: cisplatin 75mg/m2 on day 1 plus gemcitabine 1000 mg/m2 on days 1 and 8
Measure Participants	144	144
Median (95% Confidence Interval) [day]	168	140

2. Secondary Outcome

Title	Response Rate
Time Frame	6 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group A	Group B
Arm/Group Description	cisplatin, dexamethasone,vitamin B12, folic acid: Patients received cisplatin 75mg/m2 plus pemetrexed 500 mg/m2 on day 1.Chemotherapy was repeated every 3 weeks for a maximum of six cycles.Patients received dexamethasone prophylaxis of 3.75mg orally twice per day on the day before, the day of, and the day after each day-1 treatment. patients received oral folic acid (1,000ug)daily and a vitamin B12 injection (1,000 ug) every 9 weeks, beginning 1 to 2 weeks before the first dose and continuing until 3 weeks after the last dose of study treatment	cisplatin, gemcitabine: cisplatin 75mg/m2 on day 1 plus gemcitabine 1000 mg/m2 on days 1 and 8
Measure Participants	127	127
Number [percentage]	24.41	14.17

Adverse Events

Time Frame	From the delivery of the study drug to 21 days post the last dose of study drug.
Arm/Group Title	Group A		Group B
Arm/Group Description	cisplatin, dexamethasone,vitamin B12, folic acid: Patients received cisplatin 75mg/m2 plus pemetrexed 500 mg/m2 on day 1.Chemotherapy was repeated every 3 weeks for a maximum of six cycles.Patients received dexamethasone prophylaxis of 3.75mg orally twice per day on the day before, the day of, and the day after each day-1 treatment. patients received oral folic acid (1,000ug)daily and a vitamin B12 injection (1,000 ug) every 9 weeks, beginning 1 to 2 weeks before the first dose and continuing until 3 weeks after the last dose of study treatment		cisplatin, gemcitabine: cisplatin 75mg/m2 on day 1 plus gemcitabine 1000 mg/m2 on days 1 and 8
All Cause Mortality
	Group A		Group B
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Group A		Group B
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	5/144 (3.5%)		5/144 (3.5%)
Cardiac disorders
Delay hospitalization	0/144 (0%)	0	1/144 (0.7%)	1
General disorders
Death	1/144 (0.7%)	1	1/144 (0.7%)	1
Life threatening	1/144 (0.7%)	1	1/144 (0.7%)	1
Respiratory, thoracic and mediastinal disorders
Leading to Hospitalization	3/144 (2.1%)	3	2/144 (1.4%)	2
Other (Not Including Serious) Adverse Events
	Group A		Group B
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	131/144 (91%)		140/144 (97.2%)
Blood and lymphatic system disorders
leukopenia	63/144 (43.8%)	63	69/144 (47.9%)	69
neutropenia	64/144 (44.4%)	64	59/144 (41%)	59
anemia	34/144 (23.6%)	34	48/144 (33.3%)	48

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.