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A Phase 1-2 Study of Weekly OGX-011 Plus a Gemcitabine/Platinum-Based Regimen in Patients With Stage IIIB or IV Non Small Cell Lung Cancer

Phase 1/Phase 2
18 Years
Not Enrolling
Non-small Cell Lung Cancer

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Trial Information

A Phase 1-2 Study of Weekly OGX-011 Plus a Gemcitabine/Platinum-Based Regimen in Patients With Stage IIIB or IV Non Small Cell Lung Cancer

OGX-011 is an experimental drug that has been shown to increase the effectiveness of
commonly used cancer therapies such as chemotherapy, radiation and hormone therapy in
several kinds of cancer types in animals. OGX-011 is being studied in the treatment of
cancer patients in combination with chemotherapy. In humans, OGX-011 in combination with
hormone therapy has been shown to decrease the tissue levels of a protein called clusterin,
which can be overproduced in cancer cells. Clusterin has been found to block cell death and
makes cells more resistant to cancer therapy. Gemcitabine (GEM), cisplatin (CIS) and
carboplatin (CARB) have been approved by Health Canada and the Food and Drug Administration
in the United States for the treatment of patients with lung cancer.

OGX-011 was administered as a 2-hr intravenous (IV) infusion on Days -7, -5, and -3 prior to
Cycle 1, then weekly on Days 1, 8, 15 of each 21-day cycle; GEM was infused IV after OGX-011
on Days 1 and 8; either CIS or CARB was infused IV after GEM on Day 1 of each cycle. Six
cycles of treatment were planned. Most patients received OGX-011 at 640 mg, but 3 patients
received OGX-011 at 480 mg dose; OGX-011 dose groups were combined due to the small number
of patients who received 480 mg.

Inclusion Criteria

Inclusion Criteria

1. Patients must have a histologically or cytologically confirmed diagnosis of NSCLC and
must not have had chemotherapy or biological therapy for their disease.

2. 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.

3. Life expectancy of ≥ 12 weeks

4. 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.

5. 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.

6. 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).

7. ECOG status must be ≤ 1

Exclusion Criteria

1. Prior chemotherapy or biological therapy (approved or experimental) for NSCLC,
including adjuvant and neoadjuvant treatment.

2. 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.

3. 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).

4. 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.)

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective Response Rate of OGX-011 in Combination With Gemcitabine/Platinum-based Regimen

Outcome Description:

Per RECIST Criteria V 1.0 and based on radiographic evaluations a subject was defined as having an objective response (OR) if the subject achieved either a confirmed partial response (PR) or confirmed complete response (CR). The evaluations were conducted after every two cycles of treatment for a maximum of 6 cycles. CR: disappearance of clinical/radiological evidence of tumor. PR: >= 30% decrease in the sum of the longest diameter of target lesions. SD: did not fulfill the criteria for CR or PR but not progressive disease.

Outcome Time Frame:

Based on assessments at baseline and after Cycles 2, 4, and 6. All subjects were followed for survival for a minimum of 3 years after the first dose of OGX-011 or until death.

Safety Issue:


Principal Investigator

Janessa Laskin, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

BCCA, Vancouver Clinic


United States: Food and Drug Administration

Study ID:




Start Date:

November 2004

Completion Date:

March 2010

Related Keywords:

  • Non-Small Cell Lung Cancer
  • custirsen sodium
  • OGX-011
  • Stage IIIB or IV advanced non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



Cancer Centers of the Carolinas Greenville, South Carolina  29605
Mary Crowley Medical Research Center Dallas, Texas  75246
Oregon Health and Science University Portland, Oregon  97201
New York Oncology Hematology Albany, New York  12208
University of Southern California Norris Los Angeles, California  90033
LAC-USC Medical Center Los Angeles, California  90033