ABI-007 in Treating Patients With Chemotherapy-Naïve Stage IV Non-Small Cell Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00077246
Recruitment Status : Completed
First Posted : February 11, 2004
Last Update Posted : November 6, 2013
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Drugs used in chemotherapy, such as ABI-007, work in different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: This phase I/II trial is studying the side effects and best dose of ABI-007 and to see how well it works in treating patients with stage IV non-small cell lung cancer.

Condition or disease Intervention/treatment Phase
Lung Cancer Drug: paclitaxel albumin-stabilized nanoparticle formulation Phase 1 Phase 2

Detailed Description:



  • Determine the maximum tolerated dose and dose-limiting toxicity of paclitaxel (albumin-stabilized Nanoparticle formulation) (ABI-007) in patients with chemotherapy-naïve stage IV non-small cell lung cancer.
  • Determine the antitumor activity of this drug in these patients.
  • Determine the safety and tolerability of this drug in these patients.


  • Determine the time to disease progression in patients treated with this drug.
  • Determine duration of response in patients treated with this drug.
  • Determine survival of patients treated with this drug.

OUTLINE: This is an open-label, dose-escalation study.

  • Phase I: Patients receive paclitaxel (albumin-stabilized Nanoparticle formulation) (ABI-007) IV on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of ABI-007 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

  • Phase II: Patients receive ABI-007 as above at the MTD (determined in phase I). Patients are followed monthly for 6 months and then every 3 months for 1.5 years.

PROJECTED ACCRUAL: A total of 64 patients will be accrued for this study.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Phase I/II Trial Of ABI-007 (A CREMOPHOR® El-Free, Protein Stabilized, Nanoparticle Paclitaxel) Administered Weekly In Chemotherapy Naive Patients With Advanced Non-Small Cell Lung Cancer
Study Start Date : September 2003
Actual Primary Completion Date : October 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
Drug Information available for: Paclitaxel

Primary Outcome Measures :
  1. Maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of ABI-007
  2. Objective target lesion response (complete or partial) as measured by RECIST criteria

Secondary Outcome Measures :
  1. Incidence of treatment-emergent adverse events and serious adverse events
  2. Nadir of myelosuppression
  3. Changes in hematologic and clinical chemistry values
  4. Changes in physical examination
  5. Incidence of dose modifications, dose interruptions, and/or premature discontinuation of study treatment
  6. Percentage of patients with stable disease for ≥ 16 weeks
  7. Percentage of patients with complete or partial target response (total response)
  8. Time to disease progression
  9. Duration of response
  10. Survival

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically or cytologically confirmed stage IV non-small cell lung cancer

    • Evidence of inoperable local recurrence or metastasis

      • Bone metastases or other nonmeasurable disease may not be only evidence of metastasis
  • Measurable disease documented radiographically
  • No evidence of active brain metastases or leptomeningeal involvement



  • 18 and over

Performance status

  • ECOG 0-1 OR
  • Karnofsky 80-100%

Life expectancy

  • More than 12 weeks


  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 9 g/dL


  • AST and ALT ≤ 2.5 times upper limit of normal (ULN)
  • Bilirubin normal
  • Alkaline phosphatase ≤ 2.5 times ULN (unless due to bone metastases and there is no radiologic evidence of hepatic metastases)


  • Creatinine ≤ 1.5 mg/dL


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective barrier contraception for 1 month before and during study participation
  • No prior allergy or hypersensitivity to study drug
  • No other concurrent active malignancy
  • No pre-existing peripheral neuropathy grade 1 or greater
  • No other concurrent clinically significant illness
  • No concurrent serious medical risk factor involving any of the major organ systems that would preclude study participation


Biologic therapy

  • Not specified


  • No prior chemotherapy for metastatic disease
  • More than 4 weeks since prior cytotoxic chemotherapy
  • No concurrent doxorubicin
  • No other concurrent taxanes
  • No concurrent anthracyclines

Endocrine therapy

  • Not specified


  • At least 3 weeks since prior radiotherapy to a major bone marrow-containing area
  • More than 4 weeks since prior radiotherapy except to a non-target lesion

    • Prior radiotherapy to a target lesion allowed provided there has been clear progression of the lesion since completion of radiotherapy


  • Not specified


  • Prior epidermal growth factor-targeted therapy allowed
  • More than 4 weeks since prior investigational drugs
  • No concurrent enrollment in another clinical trial in which investigational drugs are administered or investigational procedures are performed
  • No concurrent treatment with any of the following:

    • Ritonavir
    • Saquinavir
    • Indinavir
    • Nelfinavir
  • No concurrent anticonvulsants
  • No other concurrent anticancer drugs
  • No other concurrent investigational drugs

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00077246

United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI)
Study Chair: Naiyer Rizvi, MD Memorial Sloan Kettering Cancer Center

Publications of Results: Identifier: NCT00077246     History of Changes
Other Study ID Numbers: CDR0000350076
First Posted: February 11, 2004    Key Record Dates
Last Update Posted: November 6, 2013
Last Verified: December 2009

Keywords provided by National Cancer Institute (NCI):
stage IV non-small cell lung cancer
recurrent non-small cell lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action