Trial of ABI-007 Administered Weekly in Chemotherapy Naive Patients With Advanced Non-Small Cell Lung Cancer

NCT00073723 | Completed Phase 1

• 1 other identifier: CA015
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

The anticancer agent paclitaxel (Taxol for Injection Concentrate, Bristol-Meyers Squibb) has a broad spectrum of activity against several human cancers including carcinomas of ovary, breast, lung, esophagus and head and neck cancer. Taxol has shown remarkable activity against metastatic breast cancer, yielding response rates in the range of 40% to 60% in chemotherapy-naive patients and 25%-30% in patients refractory to anthracycline-containing regimens (Taxol package insert). The major limitation of Taxol is its poor water soluability requiring Cremophor (containing castor oil and ethanol) as a solvent. Taxol in this vehicle must be administered over 3-24 hours, and hypersensitivity reactions to Cremophor require a premedication routine of a corticosteroid, an antihistamine, and an H2 antagonist.

Conditions

Non-Small Cell Lung Cancer

Keywords

Non-Small Cell Lung Cancer; Taxol; Advanced Non-Small Cell Lung Cancer

Interventions

ABI-007 DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Celgene Corporation: lead

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

Related 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(R)) given as a two-hour infusion. Cancer Chemother Pharmacol. 2011 Nov;68(5):1331-7. doi: 10.1007/s00280-011-1621-0. Epub 2011 Apr 3.

  PMID: 21461889 BACKGROUND

• 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. J Clin Oncol. 2008 Feb 1;26(4):639-43. doi: 10.1200/JCO.2007.10.8605.

  PMID: 18235124 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Albumin-Bound Paclitaxel

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2003
• First Posted: December 5, 2003
• Study Start: December 1, 2003
• Study Completion: January 1, 2007
• Last Updated: December 15, 2016

Record last verified: 2016-12

Locations

US (1)