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A Phase II Clinical Trial of Angiotensin 1-7 For the Second or Third Line Treatment of Patients With Metastatic or Unresectable Sarcomas

Phase 2
18 Years
Open (Enrolling)
Kidney Cancer, Ovarian Cancer, Sarcoma

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Trial Information

A Phase II Clinical Trial of Angiotensin 1-7 For the Second or Third Line Treatment of Patients With Metastatic or Unresectable Sarcomas



- To evaluate the response rate in patients with chemotherapy-refractory, metastatic or
unresectable sarcoma treated with therapeutic angiotensin-(1-7).

- To evaluate toxicities associated with this treatment in these patients.


- To assess time to progression and overall survival of patients treated with therapeutic

- To evaluate accumulation of therapeutic angiotensin-(1-7) after 21 days of continuous
treatment and quantify changes in plasma levels of angiogenic peptides including
placental-growth factor.

OUTLINE: Patients receive therapeutic angiotensin-(1-7) subcutaneously once daily. Treatment
continues daily in the absence of disease progression or unacceptable toxicity.

Blood samples are collected periodically for pharmacokinetic and other biomarker analyses.

After completion of study treatment, patients are followed up every 3 months for 2 years,
every 6 months for 3 years, and then annually thereafter.

Inclusion Criteria


- Histologically or cytologically confirmed sarcoma

- Metastatic or unresectable disease

- Disease progressed after 1 or 2 prior treatment regimens with chemotherapy or
targeted anticancer agents such as imatinib mesylate

- Measurable disease, defined as at least one lesion that can be accurately measured in
at least one dimension as > 10 mm

- At least 4 weeks since prior radiation or chemotherapy (6 weeks for melphalan,
nitrosoureas, or mitomycin C)

- ECOG performance status 0-2

- ANC ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

- Total bilirubin < 2 mg/dL

- AST/ALT < 3 times upper limit of normal

- Creatinine clearance > 30 mL/min

- Negative pregnancy test

- Fertile patients must use effective contraception


- Pregnant or nursing

- Uncontrolled concurrent 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

- Psychiatric illness or social situations that would limit compliance with study

- Evidence of bleeding diathesis

- Concurrent angiotensin-converting enzyme inhibitors or angiotensin II receptor

- Concurrent investigational agents for cancer treatment

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective tumor response according to RECIST criteria

Safety Issue:


Principal Investigator

W. Jeffrey Petty, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Comprehensive Cancer Center of Wake Forest University


United States: Food and Drug Administration

Study ID:




Start Date:

October 2009

Completion Date:

October 2013

Related Keywords:

  • Kidney Cancer
  • Ovarian Cancer
  • Sarcoma
  • stage III adult soft tissue sarcoma
  • stage IV adult soft tissue sarcoma
  • recurrent adult soft tissue sarcoma
  • clear cell sarcoma of the kidney
  • metastatic osteosarcoma
  • ovarian sarcoma
  • recurrent osteosarcoma
  • recurrent uterine sarcoma
  • stage III uterine sarcoma
  • stage IV uterine sarcoma
  • Carcinoma, Renal Cell
  • Kidney Neoplasms
  • Ovarian Neoplasms
  • Sarcoma



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