Angiotensin-(1-7) in Treating Patients With Metastatic or Unresectable Solid Tumors

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier:
NCT00471562
First received: May 8, 2007
Last updated: February 27, 2013
Last verified: June 2012

May 8, 2007
February 27, 2013
March 2007
October 2009   (final data collection date for primary outcome measure)
  • Maximum tolerated dose [ Time Frame: 21 days ] [ Designated as safety issue: Yes ]
  • Toxicity [ Time Frame: 105 days ] [ Designated as safety issue: Yes ]
  • Maximum tolerated dose
  • Toxicity
Complete list of historical versions of study NCT00471562 on ClinicalTrials.gov Archive Site
Response rate (complete or partial response) as measured by RECIST criteria [ Time Frame: 105 days ] [ Designated as safety issue: No ]
Response rate (complete or partial response) as measured by RECIST
Not Provided
Not Provided
 
Angiotensin-(1-7) in Treating Patients With Metastatic or Unresectable Solid Tumors
Phase I Clinical Trial of Angiotensin 1-7 for Advanced Solid Tumors

RATIONALE: Angiotensin-(1-7) may stop the growth of solid tumors by blocking blood flow to the tumor.

PURPOSE: This phase I trial is studying the side effects and best dose of angiotensin-(1-7) in treating patients with metastatic or unresectable solid tumors.

OBJECTIVES:

Primary

  • Determine the maximum tolerated dose of therapeutic angiotensin-(1-7) in patients with metastatic or unresectable solid tumors.
  • Determine the pharmacokinetics of this drug in these patients.

Secondary

  • Determine tumor response in patients treated with this drug.

OUTLINE: This is a dose-escalation study.

Patients receive therapeutic angiotensin-(1-7) subcutaneously on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of therapeutic angiotensin-(1-7) until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity during the first 3 weeks of study therapy. At least 6 patients are treated at the MTD.

Blood samples are collected from patients after the first and fifth doses of the study drug for pharmacokinetic correlative studies.

PROJECTED ACCRUAL: A total of 18 patients will be accrued for this study.

Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Unspecified Adult Solid Tumor, Protocol Specific
Biological: therapeutic angiotensin-(1-7)
sequentially increasing doses 50-1000 mcg/kg
Not Provided
Petty WJ, Miller AA, McCoy TP, Gallagher PE, Tallant EA, Torti FM. Phase I and pharmacokinetic study of angiotensin-(1-7), an endogenous antiangiogenic hormone. Clin Cancer Res. 2009 Dec 1;15(23):7398-404. Epub 2009 Nov 17.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
Not Provided
October 2009   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed advanced solid tumor meeting 1 of the following criteria:

    • Metastatic disease
    • Unresectable disease
  • Standard curative or palliative measures do not exist or are no longer effective
  • Measurable or nonmeasurable disease

    • Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan
    • Nonmeasurable disease, defined as all other lesions, including small lesions (i.e., ≥ 1 unidimensionally measurable lesion < 20 mm by conventional techniques or < 10 mm by spiral CT scan) and truly nonmeasurable lesions, including any of the following:

      • Bone lesions
      • Ascites
      • Pleural or pericardial effusion
      • Lymphangitis cutis or pulmonis
      • Abdominal masses not confirmed and followed by imaging techniques
      • Cystic lesions
  • No lung cancer with recent hemoptysis
  • No brain metastasis

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • Life expectancy > 4 weeks
  • No evidence of bleeding diathesis
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Granulocyte count ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Creatinine clearance > 30 mL/min
  • Bilirubin < 2 mg/dL
  • AST and ALT < 3 times upper limit of normal
  • No concurrent uncontrolled illness including, but not limited to, any of the following:

    • Ongoing or active infection
    • Symptomatic congestive heart failure
    • Unstable angina pectoris
    • Cardiac arrhythmia
    • Uncontrolled hypertension or hypotension
  • No psychiatric illness or social situation that would preclude informed consent or study compliance

PRIOR CONCURRENT THERAPY:

  • At least 4 weeks since prior major surgery
  • At least 4 weeks since prior radiotherapy or chemotherapy (6 weeks for melphalan, nitrosoureas, or mitomycin C)
  • No concurrent therapeutic anticoagulation
  • No other concurrent investigational agents
  • No concurrent angiotensin-converting enzyme inhibitors or angiotensin II receptor blockers
  • No concurrent combination antiretroviral therapy for HIV-positive patients
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00471562
CDR0000543744, CCCWFU-99206, CCCWFU-99206/Ang 1-7, CCCWFU-IRB00001136
No
Comprehensive Cancer Center of Wake Forest University
Comprehensive Cancer Center of Wake Forest University
National Cancer Institute (NCI)
Study Chair: W. Jeffrey Petty, MD Comprehensive Cancer Center of Wake Forest University
Comprehensive Cancer Center of Wake Forest University
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP