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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
N/A
Open (Enrolling)
Both
Bone Cancer, Chondrosarcoma, Clear Cell Sarcoma of the Kidney, Metastatic Osteosarcoma, Ovarian Sarcoma, Recurrent Adult Soft Tissue Sarcoma, Recurrent Osteosarcoma, Recurrent Uterine Sarcoma, Stage III Adult Soft Tissue Sarcoma, Stage III Uterine Sarcoma, Stage IV Adult Soft Tissue Sarcoma, Stage IV Uterine 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


PRIMARY OBJECTIVES:

I. To evaluate the response rate of chemotherapy-refractory sarcomas to 20 mg per day of
single-agent Ang(Angiotensin)-(1-7) or 10 mg per day of single-agent Ang-(1-7) if excessive
toxicity is observed at the 20 mg dose.

II. To evaluate toxicities associated with single-agent Ang-(1-7) when given to patients
with chemotherapy-refractory sarcomas.

SECONDARY OBJECTIVES:

I. To assess time to progression (TTP) and overall survival (OS) in patients treated with
Ang-(1-7).

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

OUTLINE:

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

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


Inclusion Criteria:



- Patients must have a histologically or cytologically confirmed sarcoma that is
metastatic or unresectable and have progressed despite 1 or 2 prior treatment
regimens with chemotherapy or targeted anti-cancer agents such as imatinib

- Prior treatment: >= 4 weeks since completion of radiation or chemotherapy, except for
>= 6 weeks for Melphalan, nitrosoureas, or mitomycin-C

- Eastern Cooperative Oncology Group (ECOG) performance status =< 2

- Absolute neutrophil count >= 1,500/mcL

- Platelets >= 100,000/mcL

- Total bilirubin =< 2 mg/dL

- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase
[SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) <
3 X upper limit or normal (ULN)

- Estimated (est.) creatinine clearance > 30 mL/min

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

- Women of child-bearing potential and men must agree to use adequate contraception
(hormonal or double-barrier method of birth control; abstinence) prior to study entry
and for the duration of study participation; should a woman become pregnant or
suspect she is pregnant while participating in this study, she should inform her
treating physician immediately

- Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

- Patients may not be receiving any other investigational agents for cancer treatment

- Patients with evidence of bleeding diathesis are ineligible

- No concurrent treatment with angiotensin-converting-enzyme (ACE) inhibitors or
angiotensin II receptor blockers (ARBs)

- Uncontrolled intercurrent illness including, but not limited to ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, uncontrolled hypertension or hypotension, or psychiatric illness/social
situations that would limit compliance with study requirements

- Pregnant and nursing women are excluded from this study

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Antitumor activity as assessed by objective tumor response

Outcome Description:

'Activity' will be operationalized using objective tumor response, which will be estimated as the proportion of partial and complete responders (according to Response Evaluation Criteria in Solid Tumors [RECIST] criteria) among all evaluable patients. 95% Confidence Intervals will be estimated. Fisher's exact and t-tests or Wilcoxon rank-sum tests used to assess the univariate associations of patient characteristics with response. Logistic regression used to determine which covariates are jointly predictive of response.

Outcome Time Frame:

Approximately 1 year

Safety Issue:

No

Principal Investigator

William Petty

Investigator Role:

Principal Investigator

Investigator Affiliation:

Wake Forest University

Authority:

United States: Food and Drug Administration

Study ID:

CCCWFU 71108

NCT ID:

NCT01553539

Start Date:

October 2009

Completion Date:

Related Keywords:

  • Bone Cancer
  • Chondrosarcoma
  • Clear Cell Sarcoma of the Kidney
  • Metastatic Osteosarcoma
  • Ovarian Sarcoma
  • Recurrent Adult Soft Tissue Sarcoma
  • Recurrent Osteosarcoma
  • Recurrent Uterine Sarcoma
  • Stage III Adult Soft Tissue Sarcoma
  • Stage III Uterine Sarcoma
  • Stage IV Adult Soft Tissue Sarcoma
  • Stage IV Uterine Sarcoma
  • Bone Neoplasms
  • Osteosarcoma
  • Chondrosarcoma
  • Sarcoma, Clear Cell
  • Sarcoma

Name

Location
Wake Forest University Health Sciences Winston-Salem, North Carolina  27157