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

NCT00077246 | Completed Phase 1

• 3 other identifiers: CDR0000350076MSKCC-03111ABI-CA015
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lung Cancer

Keywords

stage IV non-small cell lung cancer; recurrent non-small cell lung cancer

Outcome Measures

Primary Outcomes (2)

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

• Objective target lesion response (complete or partial) as measured by RECIST criteria

Secondary Outcomes (10)

• 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

Interventions

paclitaxel albumin-stabilized nanoparticle formulation DRUG

Eligibility Criteria

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

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

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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• National Cancer Institute (NCI): collaborator

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 RESULT

• 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 RESULT

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

Taxes

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Economics; Health Care Economics and Organizations

Study Officials

• Naiyer Rizvi, MD

  Memorial Sloan Kettering Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 10, 2004
• First Posted: February 11, 2004
• Study Start: September 1, 2003
• Primary Completion: October 1, 2008
• Last Updated: November 6, 2013

Record last verified: 2009-12

Locations

US (1)