Completed

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

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What is being tested

paclitaxel albumin-stabilized nanoparticle formulation

Drug
Who is being recruted

Lung Cancer

Over 18 Years
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: September 2003

Summary

Principal SponsorMemorial Sloan Kettering Cancer Center
Last updated: November 6, 2013
Sourced from a government-validated database.Claim as a partner
Study start date: September 1, 2003Actual date on which the first participant was enrolled.

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. 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.

Official TitleAn 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 
Principal SponsorMemorial Sloan Kettering Cancer Center
Last updated: November 6, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
64 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind
: Participants do not know which treatment they are receiving, but researchers do.

Double-blind
: Neither participants nor researchers know which treatment is given.

Triple-blind
: Participants, researchers, and outcome assessors do not know which treatment is given.

Quadruple-blind
: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Lung Cancer
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


Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives
Study Objectives
Primary Objectives

Secondary Objectives


Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Suspended
Memorial Sloan-Kettering Cancer CenterNew York, United StatesSee the location

CompletedOne Study Center