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A Phase 2, Multicenter, Two Tier Study of IMC-A12 in Combination With Depot Octreotide in Patients With Metastatic, Well or Moderately Differentiated Carcinoid or Islet Cell Carcinoma

Phase 2
18 Years
Open (Enrolling)
Carcinoma, Neuroendocrine Tumors

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Trial Information

A Phase 2, Multicenter, Two Tier Study of IMC-A12 in Combination With Depot Octreotide in Patients With Metastatic, Well or Moderately Differentiated Carcinoid or Islet Cell Carcinoma

Inclusion Criteria:

- The patient has well-differentiated or moderately-differentiated, histologically
confirmed neuroendocrine carcinoma, including carcinoid of any location and islet
cell tumors

- The patient has metastatic disease at the time of study entry

- The patient must have a tumor measurable according to Response Evaluation Criteria in
Solid Tumors (RECIST) guidelines, measurable by elevated tumor markers (eg, 24-hour
urine 5-HIAA, chromogranin A, ACTH, gastrin, or other tumor specific biochemical
markers), or both

- The patient is age ≥ 18 years

- The patient's tumor has Ki-67 expression ≤ 20%

- The patient is receiving depot octreotide therapy at the time of enrolling into the

- The patient has received 0 - 2 systemic anticancer regimens in addition to depot
octreotide, which may have included chemotherapy, interferon, antiangiogenic therapy,
other targeted treatments, or a combination of such treatments

- The patient is no longer a candidate for surgery, embolization, or radiofrequency
ablation therapy

- The patient has experienced radiographic, biochemical, and/or scintigraphic disease
progression while on a regimen that includes octreotide

- The patient has completed prior chemotherapy and/or radiotherapy with curative intent
at least 3 weeks prior to the administration of the first dose of study therapy.
Patients that have received palliative radiation therapy to bony metastases prior to
the first dose of study medication are eligible

- The patient has a life expectancy of > 3 months

- The patient has an Eastern Cooperative Oncology Group performance status (ECOG PS) of

- The patient has adequate hematologic function as defined by absolute neutrophil count
≥ 1500/μL, hemoglobin ≥ 9 g/dL, and platelet count ≥100,000/μL

- The patient has adequate hepatic function as defined by a total bilirubin ≤ 1.5 x the
upper limit of normal (ULN), and aspartate transaminase (AST) and alanine
transaminase (ALT) ≤ 3 x the ULN (or ≤ 5 x the ULN in the presence of known liver

- The patient either has adequate coagulation function as defined by international
normalized ratio (INR) ≤ 1.5 and partial thromboplastin time (PTT) no more than 5
seconds above the ULN, or is on a stable dose of anticoagulant

- The patient has adequate renal function as defined by serum creatinine ≤ 1.5 x the
institutional ULN or creatinine clearance ≥ 60 mL/min for patients with creatinine
levels above the ULN

- The patient has fasting serum glucose < 160 mg/dL and hemoglobin A1c (HgbA1c)≤ 7. If
baseline nonfasting glucose is < 160 mg/dL, fasting glucose measurement is not

- Because the teratogenicity of IMC-A12 (cixutumumab) is not known, women of
childbearing potential (WOCBP) 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

- The patient has the ability to understand and the willingness to sign a written
informed consent document

Exclusion Criteria:

- The patient has uncontrolled brain or leptomeningeal metastases

- The patient has not recovered to Grade ≤ 1 from adverse events due to agents
administered more than 4 weeks prior to study entry (except for alopecia)

- The patient is receiving any other investigational agent(s)

- The patient has received therapeutic radiolabeled somatostatin analogues

- The patient has received more than 2 prior regimens of systemic therapy in the
metastatic setting

- The patient has a history of treatment with other agents targeting the IGF receptor

- The patient has a history of allergic reactions attributed to compounds of chemical
or biologic composition similar to that of IMC-A12 (cixutumumab) or to octreotide

- The patient has poorly controlled diabetes mellitus. Patients with a history of
diabetes mellitus are allowed to participate, provided that their fasting glucose <
160 mg/dL or below the ULN and that they are on a stable dietary or therapeutic
regimen for this condition

- The patient has an uncontrolled intercurrent illness including, but not limited to,
ongoing or active infection requiring parenteral antibiotics, symptomatic congestive
heart failure, uncontrolled hypertension, clinically significant cardiac arrhythmia,
or psychiatric illness/social situations that would limit compliance with study

- The patient is pregnant or lactating

- The patient is known to be positive for infection with the human immunodeficiency

- The patient has a history of another primary cancer, with the exception of: a)
curatively resected nonmelanomatous skin cancer; b) curatively treated cervical
carcinoma in-situ; or c) other primary solid tumor curatively resected or treated
with no known active disease present and no treatment administered for the last 3

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival (PFS)

Outcome Time Frame:

Approximately 6 months

Safety Issue:


Principal Investigator

E-mail: ClinicalTrials@

Investigator Role:

Study Director

Investigator Affiliation:

ImClone LLC


United States: Food and Drug Administration

Study ID:




Start Date:

February 2009

Completion Date:

December 2013

Related Keywords:

  • Carcinoma
  • Neuroendocrine Tumors
  • Islet Cell
  • Octreotide
  • depot octreotide acetate
  • Insulin-Like Growth Factor 1
  • Metastatic, Carcinoid or Islet Cell
  • Neuroendocrine Tumors
  • Carcinoma
  • Neuroendocrine Tumors
  • Carcinoma, Islet Cell



ImClone Investigational Site Denver, Colorado  80262
ImClone Investigational Site Indianapolis, Indiana  46202
ImClone Investigational Site Bakersfield, California  93309
ImClone Investigational Site Atlanta, Georgia  30318
ImClone Investigational Site New Orleans, Louisiana  70121
ImClone Investigational Site Cleveland, Ohio  44134
ImClone Investigational Site Memphis, Tennessee  38104
ImClone Investigational Site Dallas, Texas  75230
ImClone Investigational Site Providence, Rhode Island  02903