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

Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00077246
• Other study ID #: CDR0000350076
• Secondary ID: MSKCC-03111ABI-C
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: February 10, 2004
• Last updated: November 5, 2013
• Start date: September 2003

Study information

• Verified date: December 2009
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms

Intervention

Drug:
• paclitaxel albumin-stabilized nanoparticle formulation

Locations

Country	Name	City	State
United States	Memorial Sloan-Kettering Cancer Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (2)

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®) given as a two-hour infusion. Cancer Chemother Pharmacol. 2011 Nov;68(5):1331-7. doi: — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of ABI-007			Yes
Primary	Objective target lesion response (complete or partial) as measured by RECIST criteria			No
Secondary	Incidence of treatment-emergent adverse events and serious adverse events			Yes
Secondary	Nadir of myelosuppression			No
Secondary	Changes in hematologic and clinical chemistry values			No
Secondary	Changes in physical examination			No
Secondary	Incidence of dose modifications, dose interruptions, and/or premature discontinuation of study treatment			No
Secondary	Percentage of patients with stable disease for = 16 weeks			No
Secondary	Percentage of patients with complete or partial target response (total response)			No
Secondary	Time to disease progression			No
Secondary	Duration of response			No
Secondary	Survival			No