Status:
COMPLETED
An Open Label Study in Patients With Advanced NSCLC With ABI-007(Abraxane) in Combination With Carboplatin
Lead Sponsor:
Celgene
Conditions:
Non-Small Cell Lung Cancer (NSCLC)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is an open-label dose escalation trial using ABI-007 plus carboplatin.
Detailed Description
This is a multicenter study conducted at study sites in Russia and the Ukraine where various doses of ABI-007 (Abraxane) will be given in combination with carboplatin to patients with non-small cell l...
Eligibility Criteria
Inclusion
- Histologically or cytologically confirmed NSCLC Stage IIIB with pleural effusion or evidence of inoperable local recurrence or metastasis (Stage IV).
- Male or non-pregnant and non-lactating female, and ≥ 18 years of age. ( )If a female patient is of child-bearing potential, as evidenced by regular menstrual periods, she must have a negative serum pregnancy test (β-hCG) documented within 72 hours of the first administration of study drug. ( )If sexually active, the patient must agree to utilize contraception considered adequate and appropriate by the investigator.
- No other current active malignancy.
- Measurable disease
- Patients must have received no prior therapy for the treatment of metastatic disease.
- Patient has the following blood counts at baseline:
- ( ) ANC ≥ 1.5 x 109/L; ( ) platelets ≥ 100 x 109/L; ( ) Hgb ≥ 9 g/dL.
- Patient has the following blood chemistry levels at baseline:
- ( ) AST (SGOT), ALT (SGPT) ≤ 1.5x upper limit of normal range (ULN); ( ) total bilirubin NORMAL; ( ) creatinine ≤ 1.5 mg/dL.
- Expected survival of \> 12 weeks.
- ECOG performance status 0 or 1.
- Patient or his/her legally authorized representative or guardian has been informed about the nature of the study, and has agreed to participate in the study, and signed the Informed Consent form prior to participation in any study-related activities.
Exclusion
- Evidence of active brain metastases, including leptomeningeal involvement. Prior evidence of brain metastasis permitted only if treated and stable off therapy for at least 1 month.
- The only evidence of metastasis is bone metastases or other nonmeasurable disease.
- Patient has pre-existing peripheral neuropathy of grade 2, 3, or 4.
- Patient received radiotherapy in last 4 weeks, except if to a non-target lesion only. Prior radiation to a target lesion is permitted only if there has been clear progression of the lesion since radiation was completed.
- Patient has a clinically significant concurrent illness.
- Patient is, in the investigator's opinion, unlikely to be able to complete the study through the End of Study visit.
- Patient has received treatment with any other cytotoxic chemotherapeutic agent or investigational drug within the previous 4 weeks;
- Patient has a history of allergy or hypersensitivity to the study drug.
- Patient has serious medical risk factors involving any of the major organ systems such that the investigator considers it unsafe for the patient to receive an experimental research drug.
- Patient is enrolled in any other clinical protocol or investigational trial.
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2007
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT00274443
Start Date
March 1 2005
End Date
June 1 2007
Last Update
November 12 2019
Active Locations (1)
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1
Study Sites in Russia
Saint Petersburg, Sankt-Peterburg, Russia