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A Phase II Randomized Study Evaluating the Safety and Efficacy of ABT-510 in Subjects With Advanced Renal Cell Carcinoma


Phase 2
18 Years
N/A
Not Enrolling
Both
Carcinoma, Renal Cell

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Trial Information

A Phase II Randomized Study Evaluating the Safety and Efficacy of ABT-510 in Subjects With Advanced Renal Cell Carcinoma


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Outcome Measure:

Progression free survival

Outcome Time Frame:

One year

Principal Investigator

Rod Humerickhouse, MD

Investigator Role:

Study Director

Investigator Affiliation:

Abbott

Authority:

United States: Food and Drug Administration

Study ID:

M02-428

NCT ID:

NCT00073125

Start Date:

May 2003

Completion Date:

Related Keywords:

  • Carcinoma, Renal Cell
  • Advanced histologically documented renal cell carcinoma
  • Carcinoma
  • Carcinoma, Renal Cell

Name

Location

Baylor College of MedicineHouston, Texas  77030
Arizona Cancer CenterTucson, Arizona  85724
University of MichiganAnn Arbor, Michigan  48109-0624
MD Anderson Cancer CenterHouston, Texas  77030-4096
UCLA School of MedicineLos Angeles, California  900121973
Albany Regional Cancer CenterAlbany, New York  12208
University of Chicago Medical CenterChicago, Illinois  60637
Kansas City Oncology and Hematology GroupKansas City, Missouri  64111
Raleigh Hematology Oncology ClinicCary, North Carolina  27511
Clinical Trials and Research AssociatesMontebello, California  90640
The Center for Hematology-OncologyBoca Raton, Florida  33486
Virginia G. Piper Cancer CenterScottsdale, Arizona  85724
Texas Cancer CenterAbilene, Texas  79606
Central indiana Cancer CenterIndianapolis, Indiana  46227
Kansas City Cancer Centers SouthwestOverland Park, Kansas  66210
US Oncology, P.A.Dallas, Texas  75246