Phase 2
Completed N=20
Therapeutic Angiotensin-(1-7) in Treating Patients With Metastatic Sarcoma That Cannot Be Removed By Surgery
Bone Cancer · Chondrosarcoma · Kidney Cancer · Metastatic Osteosarcoma
Source: ClinicalTrials.gov NCT01553539 ↗
Enrolled (actual)
20
Serious AEs
55.0%
Results posted
Jan 2014
Primary outcomePrimary: Antitumor Activity as Assessed by Number of Patients Showing an Objective Tumor Response — 0 participants
Summary
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)
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Antitumor Activity as Assessed by Number of Patients Showing an Objective Tumor Response |
— | — |
| PRIMARY Number of Participants Who Experienced Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 |
20 | — |
| SECONDARY Time to Disease Progression |
2.7 | — |
| SECONDARY Overall Survival |
10.2 | — |
| SECONDARY Plasma Levels of Angiogenic Peptides Including Placental Growth Factor (PlGF) |
18.4; 41.2; 21.3; 31.5; 22.5; 17.5 | — |
Eligibility Criteria
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 = = 1,500/Microliter (mcL)
- Platelets >= 100,000/mcL
- Total bilirubin = 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
Data sourced from ClinicalTrials.gov (NCT01553539). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.