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

NCT00452881 | Unknown Phase 2

• 1 other identifier: NCCCTS-05-158
• Study Type: interventional
• Target: 151
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Lung Cancer

Keywords

Non-small cell lung cancer; adjuvant chemotherapy

Outcome Measures

Primary Outcomes (1)

• Compare time to recurrence with these regimens

  the first day of the treatment to date of the tumor recurrence

Secondary Outcomes (5)

• Compare to Overall survival with these regimens

  the first day of treatment to death

• Compare to Toxicities with these regimens

  the first day of treatment to the date that disease progression is reported

• - To define the patient population most at risk for disease recurrence

  from the date of randomization to date of recurrence

• (tissue banking and blood sampling for analysis of predictive markers)

  before treatment, obtained from the resected lung cancer specimen

• Compare quality of life as assessed by EORTC QLQ-C30, EORTC QLQ-LC13 with these regimens

  before treatment and after each cycle

Study Arms (2)

study arm

EXPERIMENTAL

GemOx

Drug: gemcitabine; Drug: Oxaliplatin

control arm

ACTIVE COMPARATOR

GemCis

Drug: gemcitabine; Drug: Cisplatin

Interventions

gemcitabine DRUG

Gemcitabine1250mg/m2 iv on day 1 and 15, every 4weeks, maximum 4 cycles

control arm; study arm

Oxaliplatin DRUG

Oxaliplatin 85mg/m2 iv on day 1 and 15, every 4 weeks, maximum 4 cycles

study arm

Cisplatin DRUG

Cisplatin 40mg/m2 iv on day 1 and 15, every 4 weeks, maximum 4 cycles

control arm

Eligibility Criteria

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

You may qualify if:

• Histologic diagnosis of non-small cell lung cancer.
• Presence of pathological stage IB, II or IIIA, according to the American Joint Committee on Cancer (AJCC).
• Completely resected tumor at NCC hospital.
• No prior tumor therapy (radiotherapy, chemotherapy, immunotherapy, or any other type of tumor therapy).
• Performance status of 0-1 on ECOG scale.
• At least 18 years old
• Patient compliance that allows adequate follow-up.
• 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.
• Signed informed consent from patient or legal representative.
• 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.

You may not qualify if:

• Concurrent administration of any other tumor therapy, including radiotherapy, chemotherapy, immunotherapy.
• Active uncontrolled infection.
• Serious concomitant disorders that would compromise the safety of patient or compromise the patient's ability to tolerate therapy.
• Second primary malignancy.
• Significant neurological or mental disorder.
• Pregnant or nursing.
• MI within preceding 6 months or symptomatic heart disease including unstable angina, congestive heart failure, or uncontrolled arrhythmia

Sponsors & Collaborators

• National Cancer Center, Korea: lead

Study Sites (1)

National Cancer Center, Korea

Goyang-si, Gyeonggi-do, 411-769, South Korea

Location

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

Gemcitabine; Oxaliplatin; Cisplatin

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Coordination Complexes; Organic Chemicals; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Jae-Ill Zo, M.D.

  National Cancer Center, Korea

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: March 27, 2007
• First Posted: March 28, 2007
• Study Start: May 1, 2006
• Primary Completion: October 1, 2009
• Study Completion: December 1, 2014
• Last Updated: October 25, 2010

Record last verified: 2010-07

Locations

KR (1)