Gemcitabine Plus Oxaliplatin in Advanced Stage IIIB/IV Non Small Cell Lung Cancer (NSCLC)

NCT00453115 | Unknown Phase 2

• 1 other identifier: NCCCTS-05-157
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

Oxaliplatin is a diaminocyclohexane platinum compound, with a mechanism of action similar to that of cisplatin. Oxaliplatin has a more manageable toxicity profile than cisplatin, with no renal toxicity and a lower incidence of hematological and gastrointestinal toxicities. Gemcitabine and oxaliplatin are both active in NSCLC with no overlapping toxicity. Preclinical studies show a synergistic effect of the gemcitabine-oxaliplatin combination. The combination of gemcitabine-oxaliplatin is attractive in NSCLC patients as it may improve the therapeutic index.

Conditions

Lung Cancer

Keywords

Non small cell lung cancer; advanced stage IIIB; Stage IV

Outcome Measures

Primary Outcomes (1)

• Response rate

  every 12 weeks during until disease progression

Secondary Outcomes (4)

• To access the toxicity

  the first day of the treatment to 30 days after the last dose of study drug

• To estimate the time to progression and overall survival

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

• To evaluate the improvement quality of life

  before the first treatment and every cycle d1 until diseas progression

• To estimate the overall survival

  the first day of the treatment to death date

Study Arms (1)

study arm

EXPERIMENTAL

GemOx

Drug: Oxaliplatin; Drug: Gemcitabine

Interventions

Oxaliplatin DRUG

oxaliplatin 85mg/m2 iv on D1 and 15, every 4 weeks until disease progression

study arm

Gemcitabine DRUG

gemcitabine 1250mg/m2 iv on day 1 and 15, every 4 weeks until disease progression

study arm

Eligibility Criteria

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

You may qualify if:

• Histologic or cytologic diagnosis of NSCLC, Stage IV or selected stage IIIB (with positive pleural effusion or separate tumor nodules in the same lobe) according to the American Joint Committee on Cancer (AJCC).
• No prior chemotherapy.
• Prior radiation therapy is allowed as long as the irradiated area is not the only source of measurable disease.
• No other forms of cancer therapy, such as radiation, immunotherapy for at least 4 weeks before the enrollment in study.
• Performance status of 0, 1, 2 on the ECOG criteria.
• At least one unidimensional measurable lesion meeting Response Evaluation Criteria in Solid Tumors (RECIST. 2000).
• Estimated life expectancy of at least 12 weeks.
• Patient compliance that allow adequate follow-up.
• Adequate organ function including the following:Adequate hematologic function: WBC count ≥ 3,500/uL, absolute neutrophil count (ANC) ≥ 1,500/uL, and platelet count ≥ 100,000/uLAdequate hepatic function: bilirubin ≤ 1.5 x UNL, ALT or AST ≤ 2.5 x UNL.Adequate renal function: creatinine ≤ 1.5mg/dL.
• Informed consent from patient
• Males or females at least 18 years old.
• If female: childbearing potential either terminated by surgery, radiation, or menopause, or attenuated by use of an approved contraceptive method (intrauterine device \[IUD\], birth control pills, or barrier device) during and for 3 months after trial. If male, use of an approved contraceptive method during the study and 3 months afterwards. Females with childbearing potential must have a urine negative hCG test within 7 days prior to the study registration.

You may not qualify if:

• MI within preceding 6 months or symptomatic heart disease, including unstable angina, congestive heart failure or uncontrolled arrhythmia
• Serious concomitant infection including post obstructive pneumonia
• Second primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin or prior malignancy treated more than 5 years ago without recurrence)
• Pregnant or nursing women
• Psychiatric disorder that would preclude compliance.
• Major surgery other than biopsy within the past two weeks.

Sponsors & Collaborators

• National Cancer Center, Korea: lead

Study Sites (1)

National Cancer Center, Korea

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

Location

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

Oxaliplatin; Gemcitabine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Study Officials

• Heung Tae Kim, M.D.

  National Cancer Center, Korea

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 27, 2007
• First Posted: March 28, 2007
• Study Start: January 1, 2006
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2011
• Last Updated: October 25, 2010

Record last verified: 2010-07

Locations

KR (1)