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

This study has been terminated.
(Enrollment suspended based upon interim analysis; subjects allowed to stay on study until disease progression.)
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00061646
First received: June 2, 2003
Last updated: August 10, 2007
Last verified: August 2007
  Purpose

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.


Condition Intervention Phase
Carcinoma, Non-Small-Cell Lung
Drug: ABT-510/Thrombospondin-1 mimetic
Drug: Carboplatin/Taxol
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • Progression free survival [ Time Frame: One year ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: One year ]
  • Response rate [ Time Frame: One year ]

Enrollment: 25
Study Start Date: March 2003
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00061646

Locations
United States, Florida
Oncology-Hematology Group of South Florida
Miami, Florida, United States, 33176
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637-1470
United States, Tennessee
The West Cancer Clinic
Memphis, Tennessee, United States, 38120
United States, Wisconsin
University of Wisconsin
Madison,, Wisconsin, United States, 53792-5666
Sponsors and Collaborators
Abbott
Investigators
Study Director: Global Medical Information 1-800-633-9110 Abbott
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00061646     History of Changes
Other Study ID Numbers: M02-429
Study First Received: June 2, 2003
Last Updated: August 10, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Abbott:
Stage IIIb with pleural effusion or IV NSCLC

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carboplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014