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

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

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.

Study Overview

• Status: Unknown
• Conditions: Lung Cancer
• Intervention / Treatment: Drug: Oxaliplatin; Drug: Gemcitabine

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.

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Phase 2

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi-dog
    • Goyang-si, Gyeonggi-dog, Korea, Republic of, 411-769
      • National Cancer Center, Korea

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: study arm; GemOx	Drug: Oxaliplatin; oxaliplatin 85mg/m2 iv on D1 and 15, every 4 weeks until disease progression; Drug: Gemcitabine; gemcitabine 1250mg/m2 iv on day 1 and 15, every 4 weeks until disease progression

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Response rate	every 12 weeks during until disease progression

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: National Cancer Center, Korea
• Investigators: Principal Investigator: Heung Tae Kim, M.D., National Cancer Center, Korea

Study record dates

Study Major Dates

• Study Start: January 1, 2006
• Primary Completion (Actual): May 1, 2010
• Study Completion (Anticipated): May 1, 2011

Study Registration Dates

• First Submitted: March 27, 2007
• First Submitted That Met QC Criteria: March 27, 2007
• First Posted (Estimate): March 28, 2007

Study Record Updates

• Last Update Posted (Estimate): October 25, 2010
• Last Update Submitted That Met QC Criteria: October 22, 2010
• Last Verified: July 1, 2010

More Information

Terms related to this study

• Keywords: Non small cell lung cancer; Stage IV; advanced stage IIIB
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Gemcitabine; Oxaliplatin
• Other Study ID Numbers: NCCCTS-05-157