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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
N/A
Open (Enrolling)
Both
Non-Small Cell Lung Carcinoma

Thank you

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
treatment

- 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
weeks

- 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:

Interventional

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:

No

Principal Investigator

Mark A Socinski, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of North Carolina, Chapel Hill

Authority:

United States: Food and Drug Administration

Study ID:

CA031

NCT ID:

NCT00540514

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

Name

Location

Medical University of South CarolinaCharleston, South Carolina  29425-0721
Fletcher Allen Health CareBurlington, Vermont  05401
Joe Arrington Cancer Research and Treatment CenterLubbock, Texas  79410-1894
Mary Imogene Bassett HospitalCooperstown, New York  13326
Comprehensive Blood and Cancer CenterBakersfield, California  93309
Pacific Shores Medical GroupLong Beach, California  90813
Southwest Cancer CarePoway, California  92064
Ventura County Hematology-Oncology SpecialistsOxnard, California  93030
Mercy Medical CenterBaltimore, Maryland  21202
St. Louis UniversitySt. Louis, Missouri  63110
Kentuckiana Cancer Institute, PLLCLouisville, Kentucky  40202
Little Rock Hematology Oncology AssociatesLittle Rock, Arkansas  72205
Mercy HospitalPortland, Maine  04101
Dallas Oncology Consultants, PADallas, Texas  75237
Cancer Center of KansasWichita, Kansas  67214
Maine Center for Cancer MedicineScarborough, Maine  04074
Blood and Cancer Center of East TexasTyler, Texas  75701
University of North Carolina at Chapel HillChapel Hill, North Carolina  27599
Essex Oncology of North JerseyBelleville, New Jersey  07109
Gulf Coast Oncology AssociatesSt. Petersburg, Florida  33705
Cancer Outreach Associates, PCAbingdon, Virginia  24211
Phoebe Cancer CenterAlbany, 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 SpringsHot Springs, Arkansas  71913
Comprehensice Cancer Ctr.Palms Springs, California  92262
Lake County Oncology and Hematology, PATavares, Florida  32778
St. Mary Medical Center- Oncology, Hematology PCLanghorne, Pennsylvania  19047
The Center for Cancers and Blood DisordersFort Worth, Texas  76104
Tyler Hematology OncologyTyler, Texas  75701