AzTrials
AzTrials

Gastrointestinal TumorPhase 1NCT01434069

Phase I Trial of Combination of FOLFIRI and SOM 230

A Phase 1 study testing SOM230C LAR and FOLFIRI Infusion in people with Gastrointestinal Tumor, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This is a single-arm, open-label, phase I study of combination therapy with SOM 230 and FOLFIRI. We will utilize a sequential dose-escalation design to define the maximum tolerated dose (MTD) of SOM 230 when combined with standard doses of FOLFIRI. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Gastrointestinal Tumor
What is being tested?
SOM230C LAR and FOLFIRI Infusion
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
1 siteUnited States
Study dates
Sep 2011to Dec 2015
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically proven metastatic/unresectable gastrointestinal malignancies (colon, small bowel, pancreas, gastric and esophageal cancer, etc.) not amenable to curative surgical therapy, for whom FOLFIRI can be considered a standard treatment
  • Have had at least 1 prior treatment for all GI tumors except for small bowel adenocarcinoma as FOLFIRI can be considered standard first line therapy for that particular tumor.
  • Measurable disease as per Response Evaluation Criteria in Solid Tumors (RECIST) criteria
  • ≥ 4 weeks since any major surgery, completion of radiation, or completion of all prior systemic anticancer therapy (adequately recovered from the acute toxicities of any prior therapy)
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
  • Adequate bone marrow function as shown by: absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L, Platelets ≥ 100 x 10^9/L, hemoglobin (Hgb) > 9 g/dL
Show all 11Show fewer
  • Adequate liver function as shown by: serum bilirubin ≤ 2 x upper limit of normal (ULN), and serum transaminases activity ≤ 3 x ULN
  • Adequate renal function as shown by serum creatinine ≤ 1.5 x ULN
  • Fasting serum cholesterol ≤300 mg/dL OR ≤7.75 mmol/L AND fasting triglycerides ≤ 2.5 x ULN. Note: In case one or both of these thresholds are exceeded, the patient can only be included after initiation of appropriate lipid lowering medication.
  • Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within 14 days of the administration of the first study treatment. Women must not be lactating.
  • Signed informed consent to participate in the study must be obtained from patients after they have been fully informed of the nature and potential risks by the investigator (or his/her designee) with the aid of written information

Who cannot join

  • Prior treatment with irinotecan. Irinotecan with radiation will be allowed if > 4 weeks.
  • Any cytotoxic chemotherapy, radiation, immunotherapy, or any investigational drug within the preceding 3 weeks of starting the study treatment
  • History of liver disease, such as cirrhosis or chronic active hepatitis B and C
  • History of, or current alcohol misuse/abuse within the past 12 months
  • Known gallbladder or bile duct disease, ( ie infection or cholecystitis) acute or chronic pancreatitis
  • Have undergone major surgery within 4 weeks prior to study enrollment
Show all 22Show fewer
  • Uncontrolled brain or leptomeningeal metastases, including patients who continue to require glucocorticoids for brain or leptomeningeal metastases. Patients who have been treated at least 4 weeks prior to enrollment, and have a computed tomography (CT) scan or magnetic resonance imaging (MRI) of brain within 4 weeks of enrollment, which shows no evidence of progression of disease in brain, are allowed to enroll.
  • Patients with uncontrolled diabetes mellitus defined as hemoglobin A1c (HbA1c) >8% despite therapy or a fasting plasma glucose > 1.5 ULN. Note: At the principal investigator's discretion, non-eligible patients can be re-screened after adequate medical therapy has been instituted.
  • Symptomatic cholelithiasis
  • Have congestive heart failure: New York Heart Association (NYHA) Class III or IV and unstable angina
  • History of syncope or family history of idiopathic sudden death
  • Sustained or clinically significant cardiac arrhythmias including sustained ventricular tachycardia, ventricular fibrillation, clinically significant bradycardia, advanced heart block (Mobitz II or higher atrioventricular nodal block AV)) , patients with prolonged corrected QT interval (QTc) (longer than 470 milliseconds) or a history of acute myocardial infarction within the 6 months preceding enrollment. (The "QT interval" is the time between the start of the Q wave and the end of the T wave in the cardiac electrical cycle. The "QTc" is the QT interval corrected for heart rate.)
  • Risk factors for Torsades de Pointes such as hypokalemia, hypomagnesemia, cardiac failure, clinically significant/symptomatic bradycardia, or high-grade AV block
  • Concomitant disease(s) that could prolong QT such as autonomic neuropathy (caused by diabetes or Parkinson's disease), human immunodeficiency virus (HIV), cirrhosis, uncontrolled hypothyroidism or cardiac failure
  • Patients found to have sustained ventricular tachycardia, ventricular fibrillation, advanced heart block (Mobitz II or higher AV nodal block) , prolonged QTc (average longer than 470 milliseconds) in the holter monitor at the screening time. (this only applies to patients in cohorts of 60 mg of SOM 230 or higher)
  • Concomitant medication(s) known to prolong the QT interval (patient must be off the drug for 2 weeks to be eligible)
  • Presence of active or suspected acute or chronic uncontrolled infection or with a history of immunocompromise, including a positive HIV test result
  • 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
  • Known or suspected allergy or hypersensitivity to any component of FOLFIRI, somatostatin analogues or any component of the pasireotide or octreotide long acting release (LAR) formulations
  • No active malignancy except for nonmelanoma skin cancer or in situ cervical cancer or treated cancer from which the patient has been continuously disease free more than 5 years
  • Women pregnant or breast feeding, or women/men able to conceive and unwilling to practice an effective method of birth control. WOCBP must have a negative serum pregnancy test within 14 days prior to administration of pasireotide. Oral, implantable, or injectable contraceptives may be affected by cytochrome P450 interactions, and are therefore not considered effective for this study
  • Unwilling to or unable to comply with the protocol

Trial locations and contacts

1 site in 1 country.

United States1 site

  • H. Lee Moffitt Cancer Center and Research Institute

    Tampa, Florida, 33612

Other trials in United States

About this study

Official title: Phase I Trial of Combination of FOLFIRI and SOM 230 in Advanced Gastrointestinal Malignancies

This is a single-arm, open-label, phase I study of combination therapy with SOM 230 and FOLFIRI. We will utilize a sequential dose-escalation design to define the maximum tolerated dose (MTD) of SOM 230 when combined with standard doses of FOLFIRI.

Read the detailed description

The goal of this clinical research study is to learn if the study drug SOM 230, also known as Pasireotide long-acting release (LAR), in addition to standard therapy of FOLFIRI (5FU, leucovorin, and irrinotecan) can shrink or slow the growth of gastrointestinal malignancies. The safety of this drug in combination with standard chemotherapy (FOLFIRI) will also be studied. The participant's physical state, changes in the size of the tumor, and laboratory findings taken while on-study will help us decide if Pasireotide LAR is safe and effective.

Being tested
SOM230C LAR, FOLFIRI Infusion
Keywords
colon, rectum, small bowel, pancreas, gastric, esophageal, metastatic, unresectable, GI, combination therapy, dose escalation, solid tumor
Medical subject headings
Digestive System Neoplasms, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SOM230C LARDrug

    Also called Pasireotide LAR

    Participants will be given one LAR dose injected into the muscle of the buttocks by a study nurse about once every 28 days until unacceptable toxicity or progression of the disease.

  • FOLFIRI InfusionDrug

    Also called 5-Fluorouracil (5FU), leucovorin (LV), and irrinotecan

    Standard therapy of FOLFIRI

Study groups in NCT01434069
Study groupRoleWhat they receive
Combination Therapy: FOLFIRI and SOM 230ExperimentalTreatment will be administered on an outpatient basis. FOLFIRI is administered by IV infusion every 2 weeks. The dose should be based on the patient's actual baseline body weight; the dose will be recalculated if there is a weight change of > 10% from baseline. SOM 230 will be administered as an intramuscular dose determined by the dosing schema, every 28 days.
Receives: Drug: SOM230C LAR; Drug: FOLFIRI Infusion

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum Tolerated Dose (MTD)

    To determine the maximum tolerated dose (using a standard 3+3 design), of SOM 230 and FOLFIRI.

    Measured: Average of 6 Months Per Participant

Secondary outcomes (2)

  1. Number of Participants With Adverse Events (AEs)

    Evaluate the frequency of toxicities by type and severity, and dose of study drug according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0.

    Measured: Average of 6 Months Per Participant

  2. Number of Participants With Tumor Response

    Evaluate the frequency of tumor response by dose cohort according to the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee.

    Measured: Average of 6 Months Per Participant

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Sep 2011 (estimated)
  2. Study startSep 2011
  3. Primary completionDec 2015
  4. Study completionDec 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01434069
Sponsor's protocol ID
MCC-16569
Other IDs
SOM230CUS17T
Status last verified
Dec 2015
First submitted
13 Sep 2011
Last updated
24 Dec 2015
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SOM230C LAR and FOLFIRI Infusion in people with Gastrointestinal Tumor, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Tolerated Dose (MTD) (time frame: Average of 6 Months Per Participant). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01434069.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2015.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in