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An Open -Label, Phase II Trial of Increasing Doses of ABI-007 and Carboplatin in Patients With Advanced Non Small Cell Lung Cancer (NSCLC)


Phase 2
18 Years
N/A
Not Enrolling
Both
Non-Small Cell Lung Cancer (NSCLC)

Thank you

Trial Information

An Open -Label, Phase II Trial of Increasing Doses of ABI-007 and Carboplatin in Patients With Advanced Non Small Cell Lung Cancer (NSCLC)


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 lung cancer to determine the recommended dose and schedule for this
combination therapy for Phase III trials. The primary objective of this study is to obtain
preliminary information on the antitumor activity and adverse events of ABI-007 in
combination with carboplatin.


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety Outcomes: incidence of treatment emergent adverse events.

Outcome Time Frame:

Treatment duration

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

CA028

NCT ID:

NCT00274443

Start Date:

March 2005

Completion Date:

September 2009

Related Keywords:

  • Non-Small Cell Lung Cancer (NSCLC)
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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