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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. )

Sponsored by: Abbott
Information provided by: Abbott
ClinicalTrials.gov Identifier: NCT00061646
  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 II

MedlinePlus related topics:   Cancer    Lung Cancer   

Drug Information available for:   Carboplatin    Paclitaxel   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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)

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

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


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

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

Study placed in the following topic categories:
Thoracic Neoplasms
Pleural Effusion
Non-small cell lung cancer
Respiratory Tract Diseases
Paclitaxel
Lung Neoplasms
Lung Diseases
Carboplatin
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 30, 2008




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