An Open Label Study in Patients With Advanced NSCLC With ABI-007(Abraxane) in Combination With Carboplatin

NCT00274443 | Completed Phase 2

• 1 other identifier: CA028
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open-label dose escalation trial using ABI-007 plus carboplatin.

Conditions

Non-Small Cell Lung Cancer (NSCLC)

Outcome Measures

Primary Outcomes (2)

• Safety Outcomes: incidence of treatment emergent adverse events.

  Treatment duration

• Efficacy Outcomes: percentage of patients who achieve an objective confirmed complete or partial overall antitumor response

  Treatment duration

Study Arms (1)

ABI-007 and Carboplatin

EXPERIMENTAL

ABI-007 and Carboplatin in patients with Advanced Non-Small Cell Lung Cancer.

Drug: ABI-007 (Abraxane) and Carboplatin

Interventions

ABI-007 (Abraxane) and Carboplatin DRUG

ABI-007 plus Carboplatin will be administered intravenously over 30 minutes in cycles of 3 weeks

ABI-007 and Carboplatin

Eligibility Criteria

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

You may qualify if:

• Histologically or cytologically confirmed NSCLC Stage IIIB with pleural effusion or evidence of inoperable local recurrence or metastasis (Stage IV).
• Male or non-pregnant and non-lactating female, and ≥ 18 years of age. ( )If a female patient is of child-bearing potential, as evidenced by regular menstrual periods, she must have a negative serum pregnancy test (β-hCG) documented within 72 hours of the first administration of study drug. ( )If sexually active, the patient must agree to utilize contraception considered adequate and appropriate by the investigator.
• No other current active malignancy.
• Measurable disease
• Patients must have received no prior therapy for the treatment of metastatic disease.
• Patient has the following blood counts at baseline:
• ( ) ANC ≥ 1.5 x 109/L; ( ) platelets ≥ 100 x 109/L; ( ) Hgb ≥ 9 g/dL.
• Patient has the following blood chemistry levels at baseline:
• ( ) AST (SGOT), ALT (SGPT) ≤ 1.5x upper limit of normal range (ULN); ( ) total bilirubin NORMAL; ( ) creatinine ≤ 1.5 mg/dL.
• Expected survival of \> 12 weeks.
• ECOG performance status 0 or 1.
• 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.

You may not qualify if:

• Evidence of active brain metastases, including leptomeningeal involvement. Prior evidence of brain metastasis permitted only if treated and stable off therapy for at least 1 month.
• The only evidence of metastasis is bone metastases or other nonmeasurable disease.
• Patient has pre-existing peripheral neuropathy of grade 2, 3, or 4.
• Patient received radiotherapy in last 4 weeks, except if to a non-target lesion only. Prior radiation to a target lesion is permitted only if there has been clear progression of the lesion since radiation was completed.
• Patient has a clinically significant concurrent illness.
• Patient is, in the investigator's opinion, unlikely to be able to complete the study through the End of Study visit.
• Patient has received treatment with any other cytotoxic chemotherapeutic agent or investigational drug within the previous 4 weeks;
• Patient has a history of allergy or hypersensitivity to the study drug.
• Patient has serious medical risk factors involving any of the major organ systems such that the investigator considers it unsafe for the patient to receive an experimental research drug.
• Patient is enrolled in any other clinical protocol or investigational trial.

Sponsors & Collaborators

• Celgene: lead

Study Sites (1)

Study Sites in Russia

Saint Petersburg, Sankt-Peterburg, Russia

Location

Related Publications (1)

• Socinski MA, Manikhas GM, Stroyakovsky DL, Makhson AN, Cheporov SV, Orlov SV, Yablonsky PK, Bhar P, Iglesias J. A dose finding study of weekly and every-3-week nab-Paclitaxel followed by carboplatin as first-line therapy in patients with advanced non-small cell lung cancer. J Thorac Oncol. 2010 Jun;5(6):852-61. doi: 10.1097/jto.0b013e3181d5e39e.

  PMID: 20521351 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Albumin-Bound Paclitaxel; Carboplatin

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; Coordination Complexes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2006
• First Posted: January 11, 2006
• Study Start: March 1, 2005
• Primary Completion: June 1, 2007
• Study Completion: June 1, 2007
• Last Updated: November 12, 2019

Record last verified: 2019-11

Locations

RU (1)