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

NCT ID: NCT00453115

Last Updated: 2010-10-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-01-31
• Study Completion Date: 2011-05-31

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.

Conditions

Lung Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

study arm

GemOx

Group Type: EXPERIMENTAL

Oxaliplatin

Intervention Type: DRUG

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

Gemcitabine

Intervention Type: DRUG

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

Interventions

Oxaliplatin

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

Intervention Type: DRUG

Gemcitabine

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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Center, Korea

OTHER_GOV

Sponsor Role: lead

Responsible Party

National Cancer Center, Korea

Principal Investigators

Heung Tae Kim, M.D.

Role: PRINCIPAL_INVESTIGATOR

National Cancer Center, Korea

Locations

National Cancer Center, Korea

Goyang-si, Gyeonggi-dog, South Korea

Countries

South Korea

Other Identifiers

NCCCTS-05-157

Identifier Type: -

Identifier Source: org_study_id