Angiotensin-(1-7) in Treating Patients With Metastatic or Unresectable Solid Tumors - Full Text View

Sponsors and Collaborators:	Wake Forest University National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00471562

Purpose

RATIONALE: Angiotensin-(1-7) may stop the growth of solid tumors by blocking blood flow to the tumor.

PURPOSE: This phase I trial is studying the side effects and best dose of angiotensin-(1-7) in treating patients with metastatic or unresectable solid tumors.

Condition	Intervention	Phase
Unspecified Adult Solid Tumor, Protocol Specific	Drug: therapeutic angiotensin-(1-7) Procedure: pharmacological study	Phase I

MedlinePlus related topics: Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment
Official Title:	Phase I Clinical Trial of Angiotensin 1-7 for Advanced Solid Tumors

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Maximum tolerated dose [ Designated as safety issue: Yes ]
Toxicity [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Response rate (complete or partial response) as measured by RECIST criteria [ Designated as safety issue: No ]

Estimated Enrollment:	18
Study Start Date:	March 2007
Estimated Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Primary

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.

Secondary

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

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

PATIENT CHARACTERISTICS:

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 following:
- 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

PRIOR CONCURRENT THERAPY:

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 blockers
No concurrent combination antiretroviral therapy for HIV-positive patients

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00471562

Locations

United States, North Carolina
Wake Forest University Comprehensive Cancer Center	Recruiting
Winston-Salem, North Carolina, United States, 27157-1096
Contact: Clinical Trials Office - Wake Forest University Comprehensive 336-713-6771

Sponsors and Collaborators

Wake Forest University

National Cancer Institute (NCI)

Investigators

Study Chair:

W. Jeffrey Petty, MD

Wake Forest University

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000543744, CCCWFU-99206, CCCWFU-99206/Ang 1-7, CCCWFU-IRB00001136
Study First Received:	May 8, 2007
Last Updated:	December 31, 2008
ClinicalTrials.gov Identifier:	NCT00471562
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

unspecified adult solid tumor, protocol specific

Study placed in the following topic categories:

Angiotensin I (1-7)

Additional relevant MeSH terms:

Therapeutic Uses
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009