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

NCT00061646 | Terminated Phase 2

• 1 other identifier: M02-429
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Carcinoma, Non-Small-Cell Lung

Keywords

Stage IIIb with pleural effusion or IV NSCLC

Outcome Measures

Primary Outcomes (1)

• Progression free survival

  One year

Secondary Outcomes (2)

• Overall survival

  One year

• Response rate

  One year

Interventions

ABT-510/Thrombospondin-1 mimetic DRUG

Carboplatin/Taxol DRUG

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abbott: lead

Study Sites (4)

Oncology-Hematology Group of South Florida

Miami, Florida, 33176, United States

Location

University of Chicago

Chicago, Illinois, 60637-1470, United States

Location

The West Cancer Clinic

Memphis, Tennessee, 38120, United States

Location

University of Wisconsin

Madison, Wisconsin, 53792-5666, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

CP protocol

Condition Hierarchy (Ancestors)

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

Study Officials

• Global Medical Information 1-800-633-9110

  Abbott

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 2, 2003
• First Posted: June 4, 2003
• Study Start: March 1, 2003
• Last Updated: August 14, 2007

Record last verified: 2007-08

Locations

US (4)