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

Sponsors and Collaborators:	Memorial Sloan-Kettering Cancer Center National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00077246

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 I Phase II

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Paclitaxel

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label
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

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

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

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

National Cancer Institute (NCI)

Investigators

Study Chair:

Naiyer Rizvi, MD

Memorial Sloan-Kettering Cancer Center

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications of Results:

Rizvi NA, Riely GJ, Azzoli CG, Miller VA, Ng KK, Fiore J, Chia G, Brower M, Heelan R, Hawkins MJ, Kris MG. Phase I/II trial of weekly intravenous 130-nm albumin-bound paclitaxel as initial chemotherapy in patients with stage IV non-small-cell lung cancer. J Clin Oncol. 2008 Feb 1;26(4):639-43.

Study ID Numbers:	CDR0000350076, MSKCC-03111, ABI-CA015
Study First Received:	February 10, 2004
Last Updated:	June 21, 2008
ClinicalTrials.gov Identifier:	NCT00077246
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

Study placed in the following topic categories:

Thoracic Neoplasms
Non-small cell lung cancer
Respiratory Tract Diseases
Paclitaxel
Lung Neoplasms

Lung Diseases
Carcinoma, Non-Small-Cell Lung
Recurrence
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

Therapeutic Uses
Mitosis Modulators
Tubulin Modulators
Antimitotic Agents
Antineoplastic Agents, Phytogenic
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009