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Therapeutic Angiotensin-(1-7) in Treating Patients With Metastatic Sarcoma That Cannot Be Removed By Surgery

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier:
NCT01553539
First received: March 9, 2012
Last updated: December 10, 2013
Last verified: December 2013

March 9, 2012
December 10, 2013
October 2009
January 2013   (final data collection date for primary outcome measure)
  • Antitumor Activity as Assessed by Number of Patients Showing an Objective Tumor Response [ Time Frame: Approximately 1 year ] [ Designated as safety issue: No ]
    '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.
  • Number of Participants Who Experienced Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 [ Time Frame: Approximately 1 year ] [ Designated as safety issue: Yes ]
    See the adverse event tables for specifics.
  • Antitumor activity as assessed by objective tumor response [ Time Frame: Approximately 1 year ] [ Designated as safety issue: No ]
    '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.
  • Toxicity as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 [ Time Frame: Approximately 1 year ] [ Designated as safety issue: Yes ]
    95% Confidence Intervals will be estimated. The frequency and severity of all side effects and toxicities will be tabulated and analyzed using categorical techniques.
Complete list of historical versions of study NCT01553539 on ClinicalTrials.gov Archive Site
  • Time to Disease Progression [ Time Frame: Approximately 5 years ] [ Designated as safety issue: No ]
  • Overall Survival [ Time Frame: Approximately 5 years ] [ Designated as safety issue: No ]
  • Plasma Levels of Angiogenic Peptides Including Placental Growth Factor (PlGF) [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Plasma Levels of Angiogenic Peptides Including PIGF [ Time Frame: Day 22 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Therapeutic Angiotensin-(1-7) in Treating Patients With Metastatic Sarcoma That Cannot Be Removed By Surgery
A Phase II Clinical Trial of Angiotensin 1-7 For the Second or Third Line Treatment of Patients With Metastatic or Unresectable Sarcomas

This phase II trial studies how well therapeutic angiotensin-(1-7) works as second-line therapy or third-line therapy in treating patients with metastatic sarcoma that cannot be removed by surgery. Therapeutic angiotensin-(1-7) may stop the growth of sarcoma by blocking blood flow to the tumor.

Funding Source - FDA Office of Orphan Drug Products (OOPD)

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.

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • 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
  • Drug: therapeutic angiotensin-(1-7)
    Given SC
    Other Names:
    • therapeutic Ang-(1-7)
    • TXA127
  • Other: laboratory biomarker analysis
    Correlative study
Experimental: Treatment (antiangiogenesis therapy)
Patients receive therapeutic angiotensin-(1-7) SC once daily in the absence of disease progression or unacceptable toxicity.
Interventions:
  • Drug: therapeutic angiotensin-(1-7)
  • Other: laboratory biomarker analysis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
Not Provided
January 2013   (final data collection date for primary outcome measure)

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/Microliter (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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01553539
CCCWFU 71108, NCI-2009-01259, 003936-01A2
No
Comprehensive Cancer Center of Wake Forest University
Comprehensive Cancer Center of Wake Forest University
National Cancer Institute (NCI)
Principal Investigator: William Petty Wake Forest School of Medicine
Comprehensive Cancer Center of Wake Forest University
December 2013

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