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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


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Lung Cancer

Thank you

Trial Information

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


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.

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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of ABI-007

Safety Issue:

Yes

Principal Investigator

Naiyer Rizvi, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000350076

NCT ID:

NCT00077246

Start Date:

September 2003

Completion Date:

Related Keywords:

  • Lung Cancer
  • stage IV non-small cell lung cancer
  • recurrent non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021