Safety and Effectiveness of ABT-510 Plus Combination Chemotherapy in Subjects With Non-Small Cell Lung Cancer (NSCLC)

A Phase II Single-Arm Study Evaluating the Safety and Effectiveness of ABT-510 Plus Combination Chemotherapy in Subjects With Non-Small Cell Lung Cancer (NSCLC)

The primary objective of this Phase II study is to assess the safety, pharmacokinetics and effectiveness of ABT-510 in combination with standard carboplatin/paclitaxel chemotherapy in subjects with stage IIIb or IV NSCLC.

Study Overview

• Status: Terminated
• Conditions: Carcinoma, Non-Small-Cell Lung
• Intervention / Treatment: Drug: ABT-510/Thrombospondin-1 mimetic; Drug: Carboplatin/Taxol

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33176
      • Oncology-Hematology Group of South Florida
  • Illinois
    • Chicago, Illinois, United States, 60637-1470
      • University of Chicago
  • Tennessee
    • Memphis, Tennessee, United States, 38120
      • The West Cancer Clinic
  • Wisconsin
    • Madison,, Wisconsin, United States, 53792-5666
      • University of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria

• The subject is at least 18 years of age.
• The subject has histologically or cytology documented Stage IIIB with pleural effusion or Stage IV NSCLC. The subject must have measurable disease (RECIST Criteria for Tumor Response).
• The subject has not received first line therapy for treatment of NSCLC.
• The subject must not be pregnant or lactating and all subjects (male and female) must use a contraceptive method deemed acceptable by the investigator while in the study and for up to two months following completion of therapy.
• The subject has an Eastern Cooperative Oncology Group (ECOG) performance score of 0-1.
• The subject is able to self-administer or has a caregiver who can reliably administer SC injections.

• The subject must have adequate bone marrow, renal and hepatic function as follows:

  • Bone marrow: White blood cell count (WBC) >= 3,000/mm3; Platelets; >= 100,000/mm3; Hemoglobin >= 9.0 g/dL;
  • Renal function: Serum creatinine <= 2.0 mg/dL;
  • Hepatic function: Bilirubin <= 1.5 mg/dL; AST and ALT <= 1.5 X the upper normal limit (ULN); unless liver metastases are present, then AST and ALT <= 5.0 x ULN.
• The subject has voluntarily signed and dated an Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved consent prior to any study specific procedures.

Exclusion Criteria

• The subject has a history of or currently exhibits Central Nervous System (CNS) metastasis. Brain MRI within 28 days of enrollment is required to confirm absence of CNS metastases.
• The subject is receiving therapeutic anticoagulation therapy. Low dose anticoagulation for catheter prophylaxis will be permitted; PT/PTT must be within normal limits.
• The subject has a history of or currently exhibits clinically significant cancer related events of bleeding (e.g., hemoptysis). The subject has a recent history of (within 4 weeks from Study Day 1) or currently exhibits other clinically significant events of bleeding.
• The subject has received investigational therapy within four weeks prior to study drug administration.
• The subject exhibits evidence of clinically significant uncontrolled condition(s) and/or is considered by the investigator to be unable to tolerate the proposed treatment or procedures.
• The subject has previous or current malignancies at other sites, with the exception of: Adequately treated in situ carcinoma of the cervix uteri; Basal or squamous cell carcinoma of the skin; Previous nonpulmonary malignancy confined and surgically resected with no evidence of active malignancy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Progression free survival	One year

Secondary Outcome Measures

Outcome Measure	Time Frame
Response rate	One year
Overall survival	One year

Collaborators and Investigators

• Sponsor: Abbott

Study record dates

Study Major Dates

• Study Start: March 1, 2003

Study Registration Dates

• First Submitted: June 2, 2003
• First Submitted That Met QC Criteria: June 3, 2003
• First Posted (Estimate): June 4, 2003

Study Record Updates

• Last Update Posted (Estimate): August 14, 2007
• Last Update Submitted That Met QC Criteria: August 10, 2007
• Last Verified: August 1, 2007

More Information

Terms related to this study

• Keywords: Stage IIIb with pleural effusion or IV NSCLC
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Antineoplastic Agents; Carboplatin
• Other Study ID Numbers: M02-429