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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00471562
Recruitment Status : Completed
First Posted : May 10, 2007
Last Update Posted : August 1, 2017
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Unspecified Adult Solid Tumor, Protocol Specific Biological: therapeutic angiotensin-(1-7) Phase 1

Detailed Description:



  • 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.


  • 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Clinical Trial of Angiotensin 1-7 for Advanced Solid Tumors
Study Start Date : March 2007
Actual Primary Completion Date : October 2009
Actual Study Completion Date : October 2009

Intervention Details:
    Biological: therapeutic angiotensin-(1-7)
    sequentially increasing doses 50-1000 mcg/kg

Primary Outcome Measures :
  1. Maximum tolerated dose [ Time Frame: 21 days ]
  2. Toxicity [ Time Frame: 105 days ]

Secondary Outcome Measures :
  1. Response rate (complete or partial response) as measured by RECIST criteria [ Time Frame: 105 days ]

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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


  • 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


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00471562

United States, North Carolina
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157-1096
Sponsors and Collaborators
Wake Forest University Health Sciences
National Cancer Institute (NCI)
Study Chair: W. Jeffrey Petty, MD Wake Forest University Health Sciences

Publications of Results:
Responsible Party: Wake Forest University Health Sciences Identifier: NCT00471562     History of Changes
Obsolete Identifiers: NCT01581268
Other Study ID Numbers: CDR0000543744
CCCWFU-99206/Ang 1-7
First Posted: May 10, 2007    Key Record Dates
Last Update Posted: August 1, 2017
Last Verified: June 2012

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Wake Forest University Health Sciences:
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
Angiotensin I (1-7)
Antihypertensive Agents
Vasodilator Agents