An Open Label Study in Patients With Advanced NSCLC With ABI-007(Abraxane) in Combination With Carboplatin

• Status: Completed
• Trial end date: 2007-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This is an open-label dose escalation trial using ABI-007 plus carboplatin.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Celgene; Celgene Corporation
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Paclitaxel

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.