Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II, Phase I	Treatment	Closed	18 and over	NCI, Pharmaceutical / Industry	MSKCC-03111 ABI-CA015, NCT00077246

Objectives

Primary

1. 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.
2. Determine the antitumor activity of this drug in these patients.
3. Determine the safety and tolerability of this drug in these patients.

Secondary

1. Determine the time to disease progression in patients treated with this drug.
2. Determine duration of response in patients treated with this drug.
3. Determine survival of patients treated with this drug.

Entry 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

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

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/mm³
• Platelet count ≥ 100,000/mm³
• 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

Expected Enrollment

A total of 64 patients will be accrued for this study.

Outcomes

Maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of ABI-007
Objective target lesion response (complete or partial) as measured by RECIST criteria

Incidence of treatment-emergent adverse events and serious adverse events
Nadir of myelosuppression
Changes in hematologic and clinical chemistry values
Changes in physical examination
Incidence of dose modifications, dose interruptions, and/or premature discontinuation of study treatment
Percentage of patients with stable disease for ≥ 16 weeks
Percentage of patients with complete or partial target response (total response)
Time to disease progression
Duration of response
Survival

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.

Rizvi NA, Riely GJ, Azzoli CG, et al.: 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 26 (4): 639-43, 2008.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Memorial Sloan-Kettering Cancer Center

Naiyer Rizvi, MD, Protocol chair		Ph: 212-639-3204; 800-525-2225

Registry Information
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
Trial Start Date		2003-09-23
Registered in ClinicalTrials.gov		NCT00077246
Date Submitted to PDQ		2003-12-16
Information Last Verified		2007-03-08
NCI Grant/Contract Number		CA08748

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