A Study of OGX-011/Gemcitabine/Platinum-Based Regimen in Stage IIIB/IV Non-Small Cell Lung Cancer (NSCLC)

Completed · Phase 1/Phase 2

Conditions studied: Non-small Cell Lung Cancer

In brief

This clinical study will help determine if giving OGX-011 (custirsen sodium) in combination with gemcitabine (GEM) and cisplatin (CIS) or carboplatin (CARB) is a safe and effective treatment for patients with lung cancer. This study will help to assess the safety and anti-tumor effect of OGX-011 when given to patients in combination with GEM and CIS/CARB.

Key facts

Study ID

NCT00138658

Run by

Achieve Life Sciences

People needed

85

Starts

2004-11-01

Expected to finish

2010-03-01

Last updated by the study team

2012-02-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients must have a histologically or cytologically confirmed diagnosis of NSCLC and must not have had chemotherapy or biological therapy for their disease.
• Stage IIIB (N3 and/or pleural or pericardial effusion) or IV disease that is not amenable to either surgery or radiation therapy of curative intent.
• Life expectancy of ≥ 12 weeks
• If patient has had prior radiation therapy: lesion(s) used for determination of response was not previously irradiated or has increased in size since the completion of radiotherapy; and patient has recovered from any toxicity from the radiotherapy.
• Radiotherapy to lesion(s) used for determination of response was completed at least 6 weeks prior to treatment; radiotherapy to other sites was completed at least 2 weeks prior to treatment.
• At least one unidimensionally measurable lesion meeting Response Evaluation Criteria in Solid Tumors [RECIST] (at least 10 mm in longest diameter by spiral computed tomography [CT] scan, or at least 20 mm by standard techniques).
• ECOG status must be ≤ 1

You may not qualify if…

• Prior chemotherapy or biological therapy (approved or experimental) for NSCLC, including adjuvant and neoadjuvant treatment.
• Presence of central nervous system (CNS) metastases, unless the patient has completed successful local therapy for CNS metastases, with the exception of leptomeningeal disease for which patients will be excluded. Patients must be off corticosteroids for at least 21 days prior to starting treatment.
• Second primary malignancy (except in situ carcinoma of the cervix, adequately treated non-melanomatous skin cancers, clinically localized prostate cancer, superficial bladder cancer or other malignancy treated at least 3 years previously with no evidence of recurrence).
• Patients eligible for combined modality therapy with curative intent as defined by the combination of chemotherapy, radiation therapy and/or surgery. (This criteria is intended to exclude patients with stage IIIB disease, as defined by the presence of N3 nodal status, who have been reported to have cure rates as high as 10% when treated with combined modality therapy.)

Where it is running

• LAC-USC Medical Center — Los Angeles, California, United States
• University of Southern California Norris — Los Angeles, California, United States
• New York Oncology Hematology — Albany, New York, United States
• Oregon Health and Science University — Portland, Oregon, United States
• Cancer Centers of the Carolinas — Greenville, South Carolina, United States
• Mary Crowley Medical Research Center — Dallas, Texas, United States
• Tom Baker Cancer Centre — Calgary, Alberta, Canada
• BC Cancer Agency, Fraser Valley Centre — Surrey, British Columbia, Canada
• BC Cancer Agency, Vancouver Center — Vancouver, British Columbia, Canada
• Dr. H. Bliss Murphy Cancer Center — St. John's, Newfoundland and Labrador, Canada
• Royal Victoria Hospital of Barrie — Barrie, Ontario, Canada
• London Regional Cancer Centre — London, Ontario, Canada
• Ottawa Hospital — Ottawa, Ontario, Canada
• Toronto Sunnybrook Regional Cancer Center — Toronto, Ontario, Canada
• Hopital Laval — Ste-Foy, Quebec, Canada

Full record on ClinicalTrials.gov

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