Know Cancer

or
forgot password

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
Non-Small Cell 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


ABI-007, a unique protein formulation of paclitaxel, has been developed to reduce the
toxicities associated with Taxol and Cremophor EL/ethanol vehicle while maintaining or
improving the chemotherapeutic effect of the drug.

The activity of ABI-007 in other malignancies is not yet well established. This open-label
Phase I/II study is being conducted to define the maximum tolerated dose (MTD) and
dose-limiting toxicities (DLT) of ABI-007, and evaluate the safety and antitumor activity of
ABI-007 in patients with advanced Stage IV non-small cell lung cancer (NSCLC).

Inclusion Criteria


Patients must be:

- Histologically or cytologically confirmed advanced stage IV NSCLC with evidence of
inoperable local recurrence or metastasis

- If female, non-pregnant and not lactating, with a negative serum pregnancy test, and
either not of child-bearing potential or practicing an approved contraception method

- Eighteen years of age or older

- No other current active malignancy

- Measurable disease (defined by RECIST criteria) documented radiographically

- Patient must have received no prior chemotherapies for the treatment of metastatic
disease. Radiation therapy to a major bone marrow-containing area must have been
completed 3 or more weeks prior to study entry. Prior treatment with EGF-targeted
therapies is permitted.

- If, at baseline, patient has ANC greater than or equal to 1.5 x 109 cells/L;
platelets greater than or equal to 100 x 109 cells/L and Hgb greater than or equal to
9 g/dL

- If, at baseline, patient has AST and ALT of less than or equal to 2.5 x the upper
limit of normal range; a total bilirubin NORMAL; creatinine levels less than or equal
to 1.5 mg/dL and alkaline phosphatase levels less than or equal to 2.5 x the upper
limit of normal range (unless alkaline phosphatase elevation is felt to be related to
bone metastases and there is no radiologic evidence of hepatic metastasis)

- Expected survival of greater than 12 weeks

- ECOG performance status 0-1 (Karnofsky > 70)

- Patient or his/her legally authorized representative or guardian has been informed
about the nature of the study, and has agreed to participate in the study, and signed
the Informed Consent form prior to participation in any study-related activities.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Authority:

United States: Food and Drug Administration

Study ID:

CA015

NCT ID:

NCT00073723

Start Date:

December 2003

Completion Date:

January 2007

Related Keywords:

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

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021