Clinical trial NCT00061646: Safety and Effectiveness of ABT-510 Plus Combination Chemotherapy in Subjects With Non-Small Cell Lung Cancer (NSCLC)
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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Carcinoma, Non-Small-Cell Lung
Keywords: Stage IIIb with pleural effusion or IV NSCLC
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2003-06-04
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Progression free survival
timeFrame: One year
Secondary outcomes:
measure: Overall survival
timeFrame: One year
measure: Response rate
timeFrame: One year
Other outcomes:
Locations:
city: Miami
country: United States
facility: Oncology-Hematology Group of South Florida
state: Florida
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Memphis
country: United States
facility: The West Cancer Clinic
state: Tennessee
city: Madison,
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: Abbott
name: Global Medical Information 1-800-633-9110
role: STUDY_DIRECTOR
References: