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Phase I Clinical Trial of Angiotensin 1-7 for Advanced Solid Tumors

Phase 1
18 Years
Not Enrolling
Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

Phase I Clinical Trial of Angiotensin 1-7 for Advanced Solid Tumors



- 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.

Inclusion Criteria


- 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

- 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

- No concurrent combination antiretroviral therapy for HIV-positive patients

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum tolerated dose

Outcome Time Frame:

21 days

Safety Issue:


Principal Investigator

W. Jeffrey Petty, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Comprehensive Cancer Center of Wake Forest University


United States: Food and Drug Administration

Study ID:




Start Date:

March 2007

Completion Date:

Related Keywords:

  • Unspecified Adult Solid Tumor, Protocol Specific
  • unspecified adult solid tumor, protocol specific
  • Neoplasms



Wake Forest University Comprehensive Cancer Center Winston-Salem, North Carolina  27157-1096