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

Lung Cancer Clinical Trial

Official title:

A Phase II Study of Gemcitabine Plus Oxaliplatin for Patients With Advanced Stage IIIB or IV Non-Small Cell Lung Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00453115
• Other study ID #: NCCCTS-05-157
• Status: Active, not recruiting
• Phase: Phase 2
• First received: March 27, 2007
• Last updated: October 22, 2010
• Start date: January 2006
• Est. completion date: May 2011

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 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 43
• Est. completion date: May 2011
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• Oxaliplatin
oxaliplatin 85mg/m2 iv on D1 and 15, every 4 weeks until disease progression
• Gemcitabine
gemcitabine 1250mg/m2 iv on day 1 and 15, every 4 weeks until disease progression

Locations

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

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	Response rate		every 12 weeks during until disease progression	No
Secondary	To access the toxicity		the first day of the treatment to 30 days after the last dose of study drug	Yes
Secondary	To estimate the time to progression and overall survival		the first day of treatment to the date that disease progression is reported	Yes
Secondary	To evaluate the improvement quality of life		before the first treatment and every cycle d1 until diseas progression	No
Secondary	To estimate the overall survival		the first day of the treatment to death date	No