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Colon CancerPhase 2FC-4NCT00845039

A Study of Irinotecan and Cetuximab With or Without IMC-A12 for Treatment of Participants With Colon or Rectum Cancer Who Got Worse After Their First Treatment With Oxaliplatin and Bevacizumab

A Phase 2 study testing Cetuximab, Irinotecan and IMC-A12 (cixutumumab) in people with Colon Cancer and Rectal Cancer, run by Eli Lilly and Company at 3 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of this study is to determine the value of adding IMC-A12 to irinotecan and cetuximab in participants with metastatic colorectal cancer (CRC). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colon Cancer, Rectal Cancer
What is being tested?
Cetuximab, Irinotecan and IMC-A12 (cixutumumab)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4 participants
Where
3 sitesUnited States
Study dates
May 2009to Feb 2011
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Must consent to be in the study and must have signed and dated Institutional Review Board (IRB)-approved consent forms conforming to federal and institutional guidelines for the pre-entry tumor sample submission for central K-RAS testing and for the study treatment
  • Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
  • Must have metastatic CRC
  • The CRC tumor or metastatic tumor must be v-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog gene (K-RAS) wild-type as determined by central testing
  • Must be documented disease progression during first-line therapy containing both oxaliplatin and bevacizumab
  • Most recent treatment regimen must have ended ≥21 days prior to randomization, and clinically significant side effects associated with previous therapy must have resolved to ≤Grade 1 with the exception of neuropathy which must have resolved to ≤Grade 2
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  • Imaging of the chest, abdomen and pelvis with computed tomography (CT) scan or magnetic resonance imaging (MRI) must be performed within 3 weeks prior to randomization
  • Must have measurable disease, defined as at least 1 lesion outside a previous radiation therapy (RT) field that can be accurately measured in at least 1 dimension as ≥20 millimeters (mm) with conventional techniques or as ≥10mm with 5mm cuts using a spiral CT scan
  • Evidence of adequate bone marrow function: absolute neutrophil (ANC) ≥1200 cubed millimeters (mm³), hemoglobin ≥9 grams per deciliter (g/dL), platelets ≥100,000 mm³
  • Evidence of adequate hepatic function. If no liver metastases: aspartate aminotransferase (AST) ≤2.5 times (x) upper limit of normal (ULN), total bilirubin ≤1.5 x ULN for the lab. In the presence of liver metastases: AST ≤5.0 x ULN, total bilirubin ≤1.5 x ULN for the lab
  • Serum creatinine must be ≤1.5 x ULN for the lab
  • Must have a fasting blood glucose <126 milligrams/deciliter (mg/dL). Fasting is defined as no caloric intake for at least 8 hours

Who cannot join

  • Life expectancy less than 12 weeks
  • Diagnosis of anal or small bowel carcinoma
  • Tumor that is considered by the surgeon to be amenable to complete resection
  • Previous RT to >25% of bone marrow
  • RT to sites of measurable disease chosen as target lesions
  • Radiological evidence and/or clinical signs or symptoms of central nervous system (CNS) metastases
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  • Any of the following conditions and events: uncontrolled hypertension, defined as systolic blood pressure (BP) >150 millimeters of mercury (mmHg) or diastolic BP >100 mmHg with or without antihypertensive medication (participants with hypertension that is well-controlled on medication are eligible); unstable angina within 6 months before randomization; New York Heart Association (NYHA) Class III or IV cardiac disease; myocardial infarction (MI) within 6 months before randomization; symptomatic arrhythmia; CNS cerebrovascular ischemia [transient ischemic attack (TIA) or stroke] within 6 months before randomization
  • Other malignancies unless the participant is considered to be disease-free and has completed therapy for the malignancy ≥12 months prior to randomization. Participants with the following cancers are eligible if diagnosed and treated within the past 12 months: carcinoma in situ of the cervix, colon carcinoma in situ, melanoma in situ, and basal cell and squamous cell carcinoma of the skin
  • Serious or non-healing wound, skin ulcers, or bone fracture
  • Any significant bleeding unless the source of bleeding has been resected
  • History of bleeding diathesis or coagulopathy (participants on stable anticoagulant therapy are eligible)
  • Any evidence of active infection
  • Active inflammatory bowel disease
  • Grade 3 or 4 diabetes mellitus as defined by National Cancer Institute's (NCI's) Common Terminology Criteria for Adverse Events (CTCAE) v 3.0 pancreatic endocrine: glucose intolerance (participants with diabetes controlled with diet and/or oral medications are eligible)
  • Symptomatic interstitial pneumonitis or definitive evidence of interstitial pneumonitis described on CT scan or chest x-ray in asymptomatic participants
  • Any other serious concomitant medical condition that, in the opinion of the investigator, would compromise the safety of the participant or compromise the participant's ability to participate in the study
  • Previous hypersensitivity reaction to monoclonal antibodies
  • Previous treatment with irinotecan, cetuximab, or any agent specifically targeting insulin-like growth factor (IGF) receptors
  • Treatment with an investigational drug within 30 days prior to randomization
  • Pregnancy or lactation at the time of participant entry
  • Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the participant from meeting the study requirements

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • ImClone Investigational Site

    Greenville, North Carolina, 27834

  • ImClone Investigational Site

    Scranton, Pennsylvania, 18510

  • ImClone Investigational Site

    Vallejo, California, 94589

Other trials in United States

About this study

Official title: A Randomized Phase II Clinical Trial Investigating Irinotecan Plus Cetuximab With or Without Anti-Insulin-Like Growth Factor-I Receptor Monoclonal Antibody (IMC-A12) for the Treatment of Patients With Metastatic K-Ras Wild Type Carcinoma of the Colon or Rectum That Has Progressed on Oxaliplatin and Bevacizumab Given as First-Line Therapy

The purpose of this study is to determine the value of adding IMC-A12 to irinotecan and cetuximab in participants with metastatic colorectal cancer (CRC).

Read the detailed description

The purpose of this study is to determine the value of adding IMC-A12 to irinotecan + cetuximab in improving progression-free survival (PFS) at 18 weeks from the date of randomization for participants with metastatic Kirsten Rat Sarcoma (K-RAS) wild-type CRC that has progressed on an oxaliplatin/bevacizumab-containing regimen.

Being tested
Cetuximab, Irinotecan, IMC-A12 (cixutumumab)
Keywords
Tumors, Antibodies, Monoclonal, Colorectal Neoplasms, Metastatic K-RAS Wild-Type Carcinoma of the Colon or Rectum
Medical subject headings
Colonic Neoplasms, Rectal Neoplasms, Neoplasms, Colorectal Neoplasms

What participants receive

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

  • CetuximabBiological

    Also called Erbitux, LY2939777

    Cetuximab 500 mg/m² every 14 days until disease progression or participant intolerance

  • IrinotecanDrug

    Also called Camptosar

    180 mg/m² every 14 days until disease progression or participant intolerance

  • IMC-A12 (cixutumumab)Biological

    Also called Cixutumumab, LY3012217

    IMC-A12 10 mg/kg every 14 days until disease progression or participant intolerance

Study groups in NCT00845039
Study groupRoleWhat they receive
Cetuximab + IrinotecanActive comparatorParticipants in Treatment Group 1 will receive intravenous infusions of Cetuximab 500 milligrams per square meter (mg/m²) and Irinotecan 180 mg/m².
Receives: Biological: Cetuximab; Drug: Irinotecan
Cetuximab + IMC-A12 + IrinotecanExperimentalParticipants in Treatment Group 2 will receive intravenous infusions of Cetuximab 500 mg/m², IMC-A12 10 milligrams/kilogram (mg/kg) and Irinotecan 180 mg/m².
Receives: Biological: Cetuximab; Drug: Irinotecan; Biological: IMC-A12 (cixutumumab)

What is being measured

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

  1. Progression-Free Survival (PFS) Rate at 18 Weeks

    Measured: Approximately 18 Weeks

Secondary outcomes (8)

  1. Objective Response Rate (ORR) [Complete Response (CR) + Partial Response (PR)]

    Measured: Randomization up to 26.3 months

  2. Overall Survival (OS)

    Measured: Randomization up to 26.3 months

  3. Progression Free Survival (PFS) Over Entire Duration

    Measured: Randomization up to 26.3 months

  4. The Number of Participants Who Had a Complete Resection/Ablation of Metastases With no Evidence of Disease Remaining (Resection Rate)

    Measured: Randomization up to 26.3 months

  5. Toxicity of the Irinotecan + Cetuximab + IMC-A12 Regimen

    Measured: Randomization up to 26.3 months

  6. Post-treatment Serum Levels of IMC-A12 in Participants Receiving IMC-A12

    Measured: Prior to infusion at Cycles 1, 4, 7 (2-week cycles), and 4 to 6 weeks following discontinuation of treatment IMC-A12 up to 77 weeks

  7. Change in Behavioral and Health Outcomes [BAHO] Quality of Life (QoL) Questionnaire

    Measured: Baseline, after Cycle 3 (14-day cycle), study discontinuation 30-day follow-up (up to 26.3 months)

  8. Serum Anti-IMC-A12 Antibody Assessment

    Measured: Prior to infusion at Cycles 1, 4, 7 (2-week cycles), and 4 to 6 weeks following discontinuation of treatment IMC-A12 up to 77 weeks

Timeline

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

  1. First posted16 Feb 2009 (estimated)
  2. Study startMay 2009
  3. Primary completionFeb 2011
  4. Study completionFeb 2011

Why it stopped: Study terminated early 22Feb2010 with only 4 participants due to business reasons.

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
4 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00845039
Sponsor's protocol ID
13928
Other IDs
CP13-0708, I5A-IE-JAED, NSABP FC-4
Acronym
FC-4
Status last verified
Jun 2018
First submitted
10 Feb 2009
Last updated
2 Jul 2018
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cetuximab, Irinotecan and IMC-A12 (cixutumumab) in people with Colon Cancer and Rectal Cancer, run by Eli Lilly and Company at 3 sites 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 12 inclusion and 21 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: stopped early, as of the sponsor's last update on 2 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Jun 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Progression-Free Survival (PFS) Rate at 18 Weeks (time frame: Approximately 18 Weeks). 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 NCT00845039.

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 2 Jul 2018.

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