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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00077246
First received: February 10, 2004
Last updated: November 5, 2013
Last verified: December 2009
  Purpose

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 Intervention Phase
Lung Cancer
Drug: paclitaxel albumin-stabilized nanoparticle formulation
Phase 1
Phase 2

Study Type: Interventional
Study Design: Masking: 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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of ABI-007 [ Designated as safety issue: Yes ]
  • Objective target lesion response (complete or partial) as measured by RECIST criteria [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of treatment-emergent adverse events and serious adverse events [ Designated as safety issue: Yes ]
  • Nadir of myelosuppression [ Designated as safety issue: No ]
  • Changes in hematologic and clinical chemistry values [ Designated as safety issue: No ]
  • Changes in physical examination [ Designated as safety issue: No ]
  • Incidence of dose modifications, dose interruptions, and/or premature discontinuation of study treatment [ Designated as safety issue: No ]
  • Percentage of patients with stable disease for ≥ 16 weeks [ Designated as safety issue: No ]
  • Percentage of patients with complete or partial target response (total response) [ Designated as safety issue: No ]
  • Time to disease progression [ Designated as safety issue: No ]
  • Duration of response [ Designated as safety issue: No ]
  • Survival [ Designated as safety issue: No ]

Estimated Enrollment: 64
Study Start Date: September 2003
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • 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.

Secondary

  • 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-1 OR
  • Karnofsky 80-100%

Life expectancy

  • More than 12 weeks

Hematopoietic

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

Hepatic

  • 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)

Renal

  • Creatinine ≤ 1.5 mg/dL

Other

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • 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

Radiotherapy

  • 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

Surgery

  • Not specified

Other

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00077246

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Study Chair: Naiyer Rizvi, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00077246     History of Changes
Other Study ID Numbers: CDR0000350076, MSKCC-03111, ABI-CA015
Study First Received: February 10, 2004
Last Updated: November 5, 2013
Health Authority: United States: Federal Government

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
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 19, 2014