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

NCT ID: NCT00077246

Last Updated: 2013-11-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-09-30

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.

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.

Conditions

Lung Cancer

Keywords

stage IV non-small cell lung cancer; recurrent non-small cell lung cancer

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

paclitaxel albumin-stabilized nanoparticle formulation

Intervention Type: DRUG

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role: lead

Principal Investigators

Naiyer Rizvi, MD

Role: STUDY_CHAIR

Memorial Sloan Kettering Cancer Center

Locations

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Countries

United States

References

Paik PK, James LP, Riely GJ, Azzoli CG, Miller VA, Ng KK, Sima CS, Heelan RT, Kris MG, Moore E, Rizvi NA. A phase 2 study of weekly albumin-bound paclitaxel (Abraxane(R)) given as a two-hour infusion. Cancer Chemother Pharmacol. 2011 Nov;68(5):1331-7. doi: 10.1007/s00280-011-1621-0. Epub 2011 Apr 3.

Reference Type: RESULT

PMID: 21461889 (View on PubMed)

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. doi: 10.1200/JCO.2007.10.8605.

Reference Type: RESULT

PMID: 18235124 (View on PubMed)

Other Identifiers

MSKCC-03111

Identifier Type: -

Identifier Source: secondary_id

ABI-CA015

Identifier Type: -

Identifier Source: secondary_id

CDR0000350076

Identifier Type: -

Identifier Source: org_study_id