A Study of Cixutumumab (IMC-A12) in Islet Cell Cancer

NCT ID: NCT00781911

Last Updated: 2019-09-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-02-28
• Study Completion Date: 2016-05-31

Brief Summary

Determine the 6-month progression free survival (PFS) rate associated with cixutumumab in combination with depot octreotide acetate (octreotide) in participants with metastatic neuroendocrine tumors.

Conditions

Carcinoma; Neuroendocrine Tumors

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Carcinoid tumor

Participants with carcinoid tumor will receive cixutumumab 10 mg/kg over 1 hour every 2 weeks. Treatment will continue until there is evidence of disease progression, intolerable toxicity, or other withdrawal criteria are met. Participants must be receiving depot octreotide at the time of enrolling into the study. Participants on stable doses of depot octreotide will continue to receive the same dose and schedule of their last regimen.

Group Type: EXPERIMENTAL

Cixutumumab

Intervention Type: BIOLOGICAL

Participants will receive cixutumumab IV 10 mg/kg over 1 hour every 2 weeks. Treatment will continue until there is evidence of disease progression, intolerable toxicity, or other withdrawal criteria are met.

depot octreotide

Intervention Type: DRUG

Participants must be receiving depot octreotide at the time of enrolling into the study. Participants on stable doses of depot octreotide will continue to receive the same dose and schedule of their last regimen.

Islet cell carcinoma

Participants with islet cell carcinoma will receive cixutumumab 10 mg/kg over 1 hour every 2 weeks. Treatment will continue until there is evidence of disease progression, intolerable toxicity, or other withdrawal criteria are met. Participants must be receiving depot octreotide at the time of enrolling into the study. Participants on stable doses of depot octreotide will continue to receive the same dose and schedule of their last regimen.

Group Type: EXPERIMENTAL

Cixutumumab

Intervention Type: BIOLOGICAL

Participants will receive cixutumumab IV 10 mg/kg over 1 hour every 2 weeks. Treatment will continue until there is evidence of disease progression, intolerable toxicity, or other withdrawal criteria are met.

depot octreotide

Intervention Type: DRUG

Participants must be receiving depot octreotide at the time of enrolling into the study. Participants on stable doses of depot octreotide will continue to receive the same dose and schedule of their last regimen.

Interventions

Cixutumumab

Participants will receive cixutumumab IV 10 mg/kg over 1 hour every 2 weeks. Treatment will continue until there is evidence of disease progression, intolerable toxicity, or other withdrawal criteria are met.

Intervention Type: BIOLOGICAL

depot octreotide

Participants must be receiving depot octreotide at the time of enrolling into the study. Participants on stable doses of depot octreotide will continue to receive the same dose and schedule of their last regimen.

Intervention Type: DRUG

Other Intervention Names

IMC-A12; LY3012217; SMS 201-995

Eligibility Criteria

Inclusion Criteria

• The participant has well-differentiated or moderately-differentiated, histologically confirmed neuroendocrine carcinoma, including carcinoid of any location and islet cell tumors
• The participant has metastatic disease at the time of study entry
• The participant 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, adrenocorticotropin hormone (ACTH), gastrin, or other tumor specific biochemical markers), or both
• The participant is age ≥ 18 years
• The participant's tumor has Ki-67 expression ≤ 20%
• The participant is receiving depot octreotide therapy at the time of enrolling into the study
• The participant 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 participant is no longer a candidate for surgery, embolization, or radiofrequency ablation therapy
• The participant has experienced radiographic, biochemical, and/or scintigraphic disease progression while on a regimen that includes octreotide
• The participant 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. Participants that have received palliative radiation therapy to bony metastases prior to the first dose of study medication are eligible
• The participant has a life expectancy of > 3 months
• The participant has an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-2
• The participant has adequate hematologic function as defined by absolute neutrophil count ≥ 1500/microliters (μL), hemoglobin ≥ 9 gram/deciliter (g/dL), and platelet count ≥100,000/μL
• The participant 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 metastases)
• The participant 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 participant has adequate renal function as defined by serum creatinine ≤ 1.5 x the institutional ULN or creatinine clearance ≥ 60 milliliter/minute (mL/min) for participants with creatinine levels above the ULN
• The participant has fasting serum glucose < 160 milligram/deciliter (mg/dL) and hemoglobin A1c (HgbA1c)≤ 7. If baseline nonfasting glucose is < 160 mg/dL, fasting glucose measurement is not required
• Because the teratogenicity of 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 participant has the ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria

• The participant has uncontrolled brain or leptomeningeal metastases
• The participant 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 participant is receiving any other investigational agent(s)
• The participant has received therapeutic radiolabeled somatostatin analogues
• The participant has received more than 2 prior regimens of systemic therapy in the metastatic setting
• The participant has a history of treatment with other agents targeting the IGF receptor
• The participant has a history of allergic reactions attributed to compounds of chemical or biologic composition similar to that of cixutumumab or to octreotide
• The participant has poorly controlled diabetes mellitus. Participants 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 participant 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 requirements
• The participant is pregnant or lactating
• The participant is known to be positive for infection with the human immunodeficiency virus
• The participant 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 years

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

ImClone Investigational Site

Los Angeles, California, United States

ImClone Investigational Site

Los Angeles, California, United States

ImClone Investigational Site

Aurora, Colorado, United States

ImClone Investigational Site

Atlanta, Georgia, United States

ImClone Investigational Site

Indianapolis, Indiana, United States

ImClone Investigational Site

Kenner, Louisiana, United States

ImClone Investigational Site

Columbus, Ohio, United States

ImClone Investigational Site

Providence, Rhode Island, United States

ImClone Investigational Site

Nashville, Tennessee, United States

ImClone Investigational Site

Dallas, Texas, United States

Countries

United States

Other Identifiers

CP13-0710

Identifier Type: OTHER

Identifier Source: secondary_id

I5A-IE-JAEE

Identifier Type: OTHER

Identifier Source: secondary_id

13929

Identifier Type: -

Identifier Source: org_study_id