Clinical trial NCT00073125: Safety and Efficacy of ABT-510 in Subjects With Advanced Renal Cell Carcinoma
Official title: A Phase II Randomized Study Evaluating the Safety and Efficacy of ABT-510 in Subjects With Advanced Renal Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Carcinoma, Renal Cell
Keywords: Advanced histologically documented renal cell carcinoma
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2003-11-18
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to assess the safety and efficacy of ABT-510 in subjects with advanced renal cell carcinoma.


Eligibility criteria: Inclusion Criteria:

A subject will be eligible for study participation if all of the following criteria are met:

* The subject is at least 18 years of age.
* The subject has advanced histologically documented renal cell carcinoma. Advanced disease is defined as locally recurrent disease or metastatic disease that is not amendable to curative resection.
* The subject has not received prior therapy (anti-tumor radiotherapy, immunotherapy, chemotherapy, or investigational therapy) for metastatic renal cell carcinoma other than excision of primary tumor where appropriate. Local radiation for supportive reasons will be allowed; however, not within 28 days from Study Day 1.
* 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 subcutaneous injections.
* The subject must have adequate bone marrow, renal, and hepatic function as follows:

  * Bone Marrow: White blood cell count (WBC) ≥ 3,000/mm3 (3.0 X 109/L); Platelets ≥ 100,000/mm3 (100 X 109/L); Hemoglobin ≥ 9.0 g/dL (1.4 mmol/L)
  * Renal function: serum creatinine ≤ 2.0 mg/dL (0.81 mmol/L)
  * Hepatic function: AST and ALT ≤ 1.5 X ULN unless liver metastases are present, then AST and ALT ≤ 5.0 X ULN; LDH ≤ 1.5 X ULN; bilirubin ≤ 1.5 mg/dL (0.026 mmol/L) Corrected calculated calcium ≤ 10 mg/dL (2.5 mmol/L) Calculation = total calcium - 0.707 (albumin -3.4)Albumin ≥ 3.0 g/dL (0.45 mmol/L)
* 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 voluntarily signed and dated an Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved consent prior to any study specific procedures.

Exclusion Criteria:

A subject will be ineligible for study participation if any of the following criteria are met:

* 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 (e.g., low dose Coumadin) 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 of Study Day 1) or currently exhibits other clinically significant signs of bleeding.
* The subject exhibits evidence of clinically significant uncontrolled conditions(s) and/or is considered by the investigator to be unable to tolerate the proposed treatment or procedures.
* The subject has history of other previous malignancies within 5 years, with the exception of: Adequately treated in situ carcinoma of the cervix uteri or Basal or squamous cell carcinoma of the skin

Primary outcomes:
measure: Progression free survival
timeFrame: One year
Secondary outcomes:
measure: Response rate
timeFrame: One year
measure: Overall survival
timeFrame: One year
measure: Performance status
timeFrame: One year
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Virginia G. Piper Cancer Center
state: Arizona
city: Tucson
country: United States
facility: Arizona Cancer Center
state: Arizona
city: Los Angeles
country: United States
facility: UCLA School of Medicine
state: California
city: Montebello
country: United States
facility: Clinical Trials and Research Associates
state: California
city: Boca Raton
country: United States
facility: The Center for Hematology-Oncology
state: Florida
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
city: Indianapolis
country: United States
facility: Central indiana Cancer Center
state: Indiana
city: Overland Park
country: United States
facility: Kansas City Cancer Centers Southwest
state: Kansas
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Kansas City
country: United States
facility: Kansas City Oncology and Hematology Group
state: Missouri
city: Albany
country: United States
facility: Albany Regional Cancer Center
state: New York
city: Cary
country: United States
facility: Raleigh Hematology Oncology Clinic
state: North Carolina
city: Dallas
country: United States
facility: US Oncology, P.A.
state: Texas
city: Fort Worth
country: United States
facility: Texas Cancer Center
state: Texas
city: Fort Worth
country: United States
facility: Texas Cancer Center
state: Texas
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Groningen
country: Netherlands
facility: Academic Hospital Groningen
Study officials:
affiliation: Abbott
name: Rod Humerickhouse, MD
role: STUDY_DIRECTOR
References: