Clinical trial NCT00453115: Gemcitabine Plus Oxaliplatin in Advanced Stage IIIB/IV Non Small Cell Lung Cancer (NSCLC)
Official title: A Phase II Study of Gemcitabine Plus Oxaliplatin for Patients With Advanced Stage IIIB or IV Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Lung Cancer
Keywords: Non small cell lung cancer
advanced stage IIIB
Stage IV
Lead sponsor: National Cancer Center, Korea
Sponsor class: OTHER_GOV
First posted: 2007-03-28
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: The combination of gemcitabine-oxaliplatin is attractive in NSCLC patients as it may improve the therapeutic index. We are conducting a phase II study to evaluate the response rate and toxicity of the gemcitabine-oxaliplatin combination both given every 4 weeks in patients with advanced NSCLC.

Eligibility criteria: Inclusion Criteria:

1. 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).
2. No prior chemotherapy.
3. Prior radiation therapy is allowed as long as the irradiated area is not the only source of measurable disease.
4. No other forms of cancer therapy, such as radiation, immunotherapy for at least 4 weeks before the enrollment in study.
5. Performance status of 0, 1, 2 on the ECOG criteria.
6. At least one unidimensional measurable lesion meeting Response Evaluation Criteria in Solid Tumors (RECIST. 2000).
7. Estimated life expectancy of at least 12 weeks.
8. Patient compliance that allow adequate follow-up.
9. 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.
10. Informed consent from patient
11. Males or females at least 18 years old.
12. 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.

Exclusion Criteria:

1. MI within preceding 6 months or symptomatic heart disease, including unstable angina, congestive heart failure or uncontrolled arrhythmia
2. Serious concomitant infection including post obstructive pneumonia
3. 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)
4. Pregnant or nursing women
5. Psychiatric disorder that would preclude compliance.
6. Major surgery other than biopsy within the past two weeks.

Primary outcomes:
measure: Response rate
timeFrame: every 12 weeks during until disease progression
Secondary outcomes:
measure: To access the toxicity
timeFrame: the first day of the treatment to 30 days after the last dose of study drug
measure: To estimate the time to progression and overall survival
timeFrame: the first day of treatment to the date that disease progression is reported
measure: To evaluate the improvement quality of life
timeFrame: before the first treatment and every cycle d1 until diseas progression
measure: To estimate the overall survival
timeFrame: the first day of the treatment to death date
Other outcomes:
Locations:
city: Goyang-si
country: Korea, Republic of
facility: National Cancer Center, Korea
state: Gyeonggi-dog
Study officials:
affiliation: National Cancer Center, Korea
name: Heung Tae Kim, M.D.
role: PRINCIPAL_INVESTIGATOR
References: