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A Randomized, Phase III Trial of ABI-007 and Carboplatin Compared With Taxol and Carboplatin as First-Line Therapy in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)

Phase 3
18 Years
Open (Enrolling)
Non-Small Cell Lung Carcinoma

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Trial Information

A Randomized, Phase III Trial of ABI-007 and Carboplatin Compared With Taxol and Carboplatin as First-Line Therapy in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)

Inclusion Criteria:

- Histologically or cytologically confirmed stage IIIB or IV NSCLC

- Male or non-pregnant and non-lactating female, and equal or greater than age 18

- If a female patient is of child-bearing potential, as evidence by regular menstrual
periods, she must have a negative serum pregnancy test (BhCG) 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

- Radiographically-documented measurable disease (defined by the presence of at least 1
radiographically documented measurable lesion)

- Patients must have received no prior chemotherapy for the treatment of metastatic
disease. Adjuvant chemotherapy permitted providing cytotoxic chemotherapy was
completed 12 months prior to starting the study

- Patient has the following blood counts at baseline:

- ANC greater than or equal to 1.5x10^9/L

- Platelets greater than or equal to 100x10^9/L

- Hgb greater than or equal to 9g/dL

- Patient has the following blood chemistry levels at baseline:

- AST (SGOT), ALT (SGPT) less than or equal to 2.5x upper limit of normal range (ULN)or
less than or equal to 5.0x ULN if liver metastases;

- total bilirubin less than or equal to ULN

- creatinine less than or equal to 1.5mg/dL

- Expected survival of greater than 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 stable 2 months after completion of

- The only evidence of disease is non-measurable

- Patient has pre-existing peripheral neuropathy of Grade 2, 3, or 4 (per CTCAE).

- 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 has received treatment with any investigational drug within the previous 4

- Patient has a history of allergy or hypersensitivity to any of the study drugs

- 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 that
involves administration of experimental therapy and/or therapeutic devices

Type of Study:


Study Design:

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

Outcome Measure:

Response rate

Outcome Description:

The percent of patients who achieved an objective confirmed complete response or partial response based on blinded radiological review using RECIST response guidelines

Outcome Time Frame:

Up to 23 months

Safety Issue:


Principal Investigator

Mark A Socinski, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of North Carolina, Chapel Hill


United States: Food and Drug Administration

Study ID:




Start Date:

November 2007

Completion Date:

December 2012

Related Keywords:

  • Non-Small Cell Lung Carcinoma
  • Advanced Non-Small Cell Lung Cancer
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



Medical University of South Carolina Charleston, South Carolina  29425-0721
Fletcher Allen Health Care Burlington, Vermont  05401
Joe Arrington Cancer Research and Treatment Center Lubbock, Texas  79410-1894
Mary Imogene Bassett Hospital Cooperstown, New York  13326
Comprehensive Blood and Cancer Center Bakersfield, California  93309
Pacific Shores Medical Group Long Beach, California  90813
Southwest Cancer Care Poway, California  92064
Ventura County Hematology-Oncology Specialists Oxnard, California  93030
Mercy Medical Center Baltimore, Maryland  21202
St. Louis University St. Louis, Missouri  63110
Kentuckiana Cancer Institute, PLLC Louisville, Kentucky  40202
Little Rock Hematology Oncology Associates Little Rock, Arkansas  72205
Mercy Hospital Portland, Maine  04101
Dallas Oncology Consultants, PA Dallas, Texas  75237
Cancer Center of Kansas Wichita, Kansas  67214
Maine Center for Cancer Medicine Scarborough, Maine  04074
Blood and Cancer Center of East Texas Tyler, Texas  75701
University of North Carolina at Chapel Hill Chapel Hill, North Carolina  27599
Essex Oncology of North Jersey Belleville, New Jersey  07109
Gulf Coast Oncology Associates St. Petersburg, Florida  33705
Cancer Outreach Associates, PC Abingdon, Virginia  24211
Phoebe Cancer Center Albany, Georgia  31701
Robert A. Moss, MD, FACP, Inc. Fountain Valley, California  92708
Pacific Cancer Medical Center, Inc. Anaheim, California  92801
Clearview Cancer Institute Oncology Specialties, P.C. Huntsville, Alabama  35805
Genesis Cancer Center- Hot Springs Hot Springs, Arkansas  71913
Comprehensice Cancer Ctr. Palms Springs, California  92262
Lake County Oncology and Hematology, PA Tavares, Florida  32778
St. Mary Medical Center- Oncology, Hematology PC Langhorne, Pennsylvania  19047
The Center for Cancers and Blood Disorders Fort Worth, Texas  76104
Tyler Hematology Oncology Tyler, Texas  75701