A Phase II Study of Ramucirumab With Somatostatin Analog Therapy in Patients With Advanced, Progressive Carcinoid Tumors

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Brief Title

A Phase II Study of Ramucirumab With Somatostatin Analog Therapy in Patients With Advanced, Progressive Carcinoid Tumors

Official Title

A Phase II Study of Ramucirumab With Somatostatin Analog Therapy in Patients With Advanced, Progressive Carcinoid Tumors

Brief Summary

      This research study is evaluating the drug Ramucirumab as a possible treatment for Advanced,
      Progressive Carcinoid Tumors.
    

Detailed Description

      This research study is a Phase II clinical trial. The purpose of this study is to test the
      safety and effectiveness of ramucirumab in advanced, progressive carcinoid tumors.

      Cancer cells can make growth factors that cause the abnormal growth of new blood vessels.
      Ramucirumab is an investigational drug which works by blocking a receptor for a vascular
      growth factor, thereby preventing new blood vessels from forming. This may stop the cancer
      from growing or spreading and the tumor cells may die.

      The FDA (the U.S. Food and Drug Administration) has not approved Ramucirumab for treatment of
      Carcinoid Tumors.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Progression Free Survival Duration

Secondary Outcome

 Number of Participants with Adverse Event

Condition

Carcinoid Tumors

Intervention

Ramucirumab

Study Arms / Comparison Groups

 Ramucirumab In Combination With Somatostatin Analog
Description:  Patients will receive treatment with Ramucirumab at a pre-determined dose intravenously every 14 days of a 28-day treatment cycle.
Patients will receive treatment with a Somatostatin Analog at a pre-determined dose.
Toxicity and adverse events will be examined in the first 10 patients who complete one cycle of therapy before expanding enrollment.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

44

Start Date

June 14, 2016

Completion Date

December 2023

Primary Completion Date

December 2020

Eligibility Criteria

        Inclusion Criteria:

          -  Participants must have histologically or cytologically confirmed low- to
             intermediate-grade neuroendocrine tumor (carcinoid tumor).

          -  Carcinoid tumors of any site are eligible. Patients with pancreatic neuroendocrine
             tumors are excluded.

          -  Participants must have measurable disease, defined as at least one lesion that can be
             accurately measured in at least one dimension (longest diameter to be recorded for
             non-nodal lesions and short axis for nodal lesions) as ≥20 mm with conventional
             techniques or as ≥10 mm with spiral CT scan, MRI, or calipers by clinical exam. See
             Section 10 for the evaluation of measurable disease.

          -  Locally advanced, unresectable or metastatic disease.

          -  Patients must have evidence of radiographic disease progression within the past 12
             months. Progressive disease by RECIST criteria is not required.

          -  Age ≥ 18 years.

          -  ECOG performance status 0-1 (see Appendix A).

          -  Participants must have normal organ and marrow function as defined below:

               -  absolute neutrophil count ≥1,000/ mm3

               -  platelets ≥100,000/ mm3

               -  hemoglobin ≥ 9 g/dL

               -  total bilirubin ≤ 1.5 × institutional upper limit of normal

               -  AST(SGOT)/ALT(SGPT) ≤ 3 × institutional upper limit of normal, or ≤ 5×
                  institutional upper limit of normal in the setting of liver metastases

               -  creatinine ≤ 1.5 × upper limit of normal

               -  urinary protein ≤ 1+ on dipstick or routine urinalysis (if urine dipstick or
                  routine urinalysis is 2+, a 24-hour urine collection for protein must demonstrate
                  <1000 mg of protein in 24 hours)

               -  coagulation function Adequate coagulation function as defined by International
                  Normalized Ratio (INR) ≤ 1.5 and a partial thromboplastin time (PTT) < 1.5 x
                  institutional upper limit of normal. Patients on full-dose anticoagulation must
                  be on a stable dose (minimum duration 14 days) of oral anticoagulant or low
                  molecular weight heparin.

               -  The effects of ramucirumab on the developing human fetus are unknown. For this
                  reason and because anti-antiangiogenic agents are known to be teratogenic, women
                  of child-bearing potential and men must agree to use adequate contraception
                  (hormonal or 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 she or her partner is participating in this study,
                  she should inform her treating physician immediately. Men treated or enrolled on
                  this protocol must also agree to use adequate contraception prior to the study,
                  for the duration of study participation, and 4 months after completion of
                  Ramucirumab administration.

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

        Exclusion Criteria:

          -  Patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering
             the study or those who have not recovered from adverse events due to agents
             administered more than 4 weeks earlier.

          -  Patients who have undergone major surgery within 28 days or subcutaneous venous access
             device placement within 7 days prior to study enrollment.

          -  Patients with elective or planned major surgery to be performed during the course of
             the clinical trial.

          -  Patients who are receiving any other investigational agents.

          -  Patients with any Grade 3-4 gastrointestinal bleeding within 3 months prior to
             enrollment.

          -  Patients with a history of deep vein thrombosis, pulmonary embolism, or any other
             significant thromboembolism (venous port or catheter thrombosis or superficial venous
             thrombosis are not considered "significant") during the 3 months prior to
             registration.

          -  Patients who have experienced any arterial thromboembolic events, including but not
             limited to myocardial infarction, transient ischemic attack, cerebrovascular accident,
             or unstable angina, within 6 months prior to enrollment.

          -  Patients with uncontrolled or poorly-controlled hypertension (>160 mmHg systolic or >
             100 mmHg diastolic for >4 weeks) despite standard medical management.

          -  Patients who have congestive heart failure (NYHA Class III or IV), sustained
             ventricular tachycardia, ventricular fibrillation, clinically significant bradycardia,
             advanced heart block within the six months preceding enrollment.

          -  Patients who have cirrhosis at a level of Child-Pugh B (or worse) or cirrhosis (any
             degree) and a history of hepatic encephalopathy or clinically meaningful ascites
             resulting from cirrhosis.

          -  Patients with a serious or nonhealing wound, ulcer, or bone fracture within 28 days
             prior to enrollment.

          -  Patients receiving chronic antiplatelet therapy, including aspirin, nonsteroidal
             anti-inflammatory drugs (NSAIDs, including ibuprofen, naproxen, and others),
             dipyridamole or clopidogrel, or similar agents. Once-daily aspirin use (maximum dose
             325 mg/day) is permitted.

          -  Patients with uncontrolled brain or leptomeningeal metastases, including patients who
             continue to require glucocorticoids for brain or leptomeningeal metastases.

          -  Patients with prior or concurrent malignancy except for the following: adequately
             treated basal cell or squamous cell skin cancer, or other adequately treated in situ
             cancer, or any other cancer from which the patient has been disease free for five
             years.

          -  Patients with symptomatic cholelithiasis.

          -  Patients who have any severe and/or uncontrolled medical conditions or other
             conditions that could affect their participation in the study such as:

               -  Severely impaired lung function

               -  Any active (acute or chronic) or uncontrolled infection/ disorders.

               -  Nonmalignant medical illnesses that are uncontrolled or whose control may be
                  jeopardized by the treatment with the study therapy

               -  Psychiatric illness/social situations that would limit compliance with study
                  requirement

          -  History of allergic reactions attributed to compounds of similar chemical or biologic
             composition to ramucirumab .

          -  Pregnant and breastfeeding women are excluded from this study because ramucirumab is
             associated with the potential for teratogenic or abortifacient effects. Because there
             is an unknown but potential risk for adverse events in nursing infants secondary to
             treatment of the mother with ramucirumab, breastfeeding should be discontinued if the
             mother is treated with ramucirumab. These potential risks may also apply to other
             agents used in this study.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Jennifer A Chan, MD MPH, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT02795858

Organization ID

16-072


Responsible Party

Principal Investigator

Study Sponsor

Dana-Farber Cancer Institute

Collaborators

 Eli Lilly and Company

Study Sponsor

Jennifer A Chan, MD MPH, Principal Investigator, Dana-Farber Cancer Institute


Verification Date

April 2020