Adjuvant Gemcitabine Plus Oxaliplatin Versus Gemcitabine Plus Cisplatin for Completely Resected Stage IB/II/IIIA NSCLC

Lung Cancer Clinical Trial

Official title:

A Randomized Phase II Study Adjuvant Gemcitabine And Oxaliplatin Versus Gemcitabine and Cisplatin for Completely Resected Stage IB, II or IIIA Non-Small Cell Lung Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00452881
• Other study ID #: NCCCTS-05-158
• Status: Active, not recruiting
• Phase: Phase 2
• First received: March 27, 2007
• Last updated: October 22, 2010
• Start date: May 2006
• Est. completion date: December 2014

Study information

• Verified date: July 2010
• Source: National Cancer Center, Korea
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial Summary

Oxaliplatin has a more manageable toxicity profile than cisplatin, with no renal toxicity and a lower incidence of hematological and gastrointestinal toxicities. The combination of gemcitabine-oxaliplatin is attractive in NSCLC patients as it may improve the therapeutic index. Given the potential advantages of oxaliplatin and th finding that the addition of chemotherapy improves survival in the postoperative adjuvant setting, we conduct a phase II trial to compare adjuvant gemcitabine-oxaliplatin with gemcitabine-cisplatin in patients with completely resected stage IB, II or IIIA NSCLC

Description:

This study is a randomized phase II study. Patients are randomized to 1 of 2 treatment arms:

patients receive adjuvant chemotherapy with gemcitabine-oxaliplatin or gemcitabine-cisplatin. Chemotherapy should be started within 8 weeks after complete surgical resection. Patients are followed every 3 months for 2 years, every 6 months for 3 years.

Gemcitabine-Oxaliplatin (GemOx) chemotherapy:

Gemcitabine (1,250 mg/m2)+Oxaliplatin (85 mg/m2) is given on day 1 and 15 q 4weeks. maximum 4 cycles.

Gemcitabine-Cisplatin (GemCis) chemotherapy:

Gemcitabine (1,250 mg/m2) + Cisplatin (40 mg/m2) is given on day 1 and 15 q 4weeks. maximum 4 cycles.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 151
• Est. completion date: December 2014
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Histologic diagnosis of non-small cell lung cancer.

2. Presence of pathological stage IB, II or IIIA, according to the American Joint Committee on Cancer (AJCC).

3. Completely resected tumor at NCC hospital.

4. No prior tumor therapy (radiotherapy, chemotherapy, immunotherapy, or any other type of tumor therapy).

5. Performance status of 0-1 on ECOG scale.

6. At least 18 years old

7. Patient compliance that allows adequate follow-up.

8. Adequate organ function including the following:Adequate hematologic function: WBC count = 4,000/uL, absolute neutrophil count (ANC) = 1,500/uL, platelet count = 100,000/uL, and hemoglobin ³ 10 gm/dL.Adequate hepatic function: bilirubin = 1.5 x UNL, ALT or AST = 2.5 x UNL.Adequate renal function: creatinine = 1.5mg/dL.

9. Signed informed consent from patient or legal representative.

10. Patients with reproductive potential must use an approved contraceptive method during and for 3 months after the study. Females with childbearing potential must have a negative urine hCG test within 7 days prior to study enrollment.

Exclusion Criteria:

1. Concurrent administration of any other tumor therapy, including radiotherapy, chemotherapy, immunotherapy.

2. Active uncontrolled infection.

3. Serious concomitant disorders that would compromise the safety of patient or compromise the patient's ability to tolerate therapy.

4. Second primary malignancy.

5. Significant neurological or mental disorder.

6. Pregnant or nursing.

7. MI within preceding 6 months or symptomatic heart disease including unstable angina, congestive heart failure, or uncontrolled arrhythmia

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms

Intervention

Drug:
• gemcitabine
Gemcitabine1250mg/m2 iv on day 1 and 15, every 4weeks, maximum 4 cycles
• Oxaliplatin
Oxaliplatin 85mg/m2 iv on day 1 and 15, every 4 weeks, maximum 4 cycles
• Cisplatin
Cisplatin 40mg/m2 iv on day 1 and 15, every 4 weeks, maximum 4 cycles

Locations

Country	Name	City	State
Korea, Republic of	National Cancer Center, Korea	Goyang-si	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Center, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compare time to recurrence with these regimens		the first day of the treatment to date of the tumor recurrence	No
Secondary	Compare to Overall survival with these regimens		the first day of treatment to death	No
Secondary	Compare to Toxicities with these regimens		the first day of treatment to the date that disease progression is reported	No
Secondary	- To define the patient population most at risk for disease recurrence		from the date of randomization to date of recurrence	No
Secondary	(tissue banking and blood sampling for analysis of predictive markers)		before treatment, obtained from the resected lung cancer specimen	No
Secondary	Compare quality of life as assessed by EORTC QLQ-C30, EORTC QLQ-LC13 with these regimens		before treatment and after each cycle	No