AzTrials
AzTrials

Colon CancerPhase 1NCT01126450

Lenalidomide and Cetuximab in Treating Patients With Metastatic Colorectal Cancer

A Phase 1 study testing lenalidomide, cetuximab and mutation analysis in people with Colon Cancer and Rectal Cancer, run by Case Comprehensive Cancer Center at 1 site in United States.

Terminated

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

Official record
Search all trials

Trial summary

RATIONALE: Lenalidomide may stop the growth of tumor cells by blocking blood flow to the tumor. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. 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?
lenalidomide, cetuximab and mutation analysis
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3 participants
Where
1 siteUnited States
Study dates
Oct 2009to Dec 2010
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

  • Wild type metastatic colorectal cancer that failed (progressed, refused or not tolerated) on at least two treatment regimens including a fluoropyrimidine, oxaliplatin and irinotecan with or without bevacizumab
  • At least 28 days must have lapsed since completion of prior chemotherapy
  • Subjects must understand and voluntarily sign an informed consent document
  • Subjects must be able to adhere to the study visit schedule and other protocol requirements
  • Histological or cytological diagnosis of colorectal carcinoma
  • Radiographic or clinical evidence of a measurable disease (by RECIST criteria)
Show all 12Show fewer
  • Subjects must have received prior treatment with at least 2 prior regimens of therapy
  • ECOG performance status of =< 1
  • Anticipated survival >= 3 months
  • Must agree to also take low dose aspirin (or other anticoagulation if unable to take ASA) while receiving study drug and for 30 days after study drug is discontinued
  • Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test within 10-14 days prior to and again within 24 hours of starting lenalidomide and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking lenalidomide; FCBP must also agree to ongoing pregnancy testing
  • Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy

Who cannot join

  • Pregnant or lactating females
  • CrCl < 50 mL/min by Cock-Croft and Gault
  • Any serious medical condition or psychiatric illness that places the subject at an unacceptable risk for study participation or would prevent the subject from signing the informed consent
  • Use of any cytotoxic chemotherapy within 28 days of study Day 1
  • Use of therapeutic radiation =< 14 days prior to study Day 1
  • Use of thalidomide, or structurally related compounds or biologic response modifier therapy within 14 days of study Day 1
Show all 26Show fewer
  • Prior desquamating rash while taking thalidomide, or structurally related compound therapy
  • Prior >= Grade 2 allergic reaction to thalidomide or structurally related compounds
  • Any prior use of Lenalidomide
  • Subjects may have received prior thalidomide
  • Known or suspected brain metastases
  • Concurrent use or anticipated use of any other anti-cancer agents (except for stable dose steroid use for control of metastases symptoms) during participation in this study
  • Absolute Neutrophil Count =< 1500/mm^3 (or 1.5 X10^9/L)
  • Platelet Count =< 100,000/mm^3 (or 100 X 10^9/L)
  • Hemoglobin < 8.0 g/dL
  • Total Bilirubin > 2.0mg/dL
  • Alanine Aminotransferase (ALT/SGPT) >= 3 x upper limit of normal (ULN)
  • Aspartate Aminotransferase (AST/SGOT) >= 3 x upper limit of normal (ULN)
  • Peripheral neuropathy >= Grade 2
  • Active infection
  • Subjects with an infection that is amenable to curative treatment may be eligible for screening once the infection has been treated, cured and not recurred for at least 14 days
  • Uncontrolled hyper- or hypo- calcemia, glycosemia or thyroidism
  • Arterial or venous thrombotic event in the preceding six months
  • Known history of HIV infection
  • Active viral hepatitis who is on active treatment
  • No other malignancies, other than previously treated non-melanoma skin cancer or carcinoma insitu of the cervix or breast

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

    Cleveland, Ohio, 44195

Other trials in United States

About this study

Official title: A Phase I, Open-Label Study To Determine The Maximum Tolerated Dose (Mtd) Of The Combination Of Lenalidomide And Cetuximab, And To Evaluate The Efficacy Of This Combination In Subjects With Wild Type K-Ras Metastatic Colorectal Carcinoma

RATIONALE: Lenalidomide may stop the growth of tumor cells by blocking blood flow to the tumor. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving lenalidomide together with cetuximab may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of lenalidomide when given together with cetuximab in treating patients with metastatic colorectal cancer.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To determine the maximum tolerated dose (MTD).

SECONDARY OBJECTIVES:

  1. To further explore the safety and efficacy profile.

OUTLINE:

This is a dose-escalation study of lenalidomide.

Patients receive oral lenalidomide once daily on days 1-28 and cetuximab IV once weekly over 1-2 hours on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 30 days.

Being tested
lenalidomide, cetuximab, mutation analysis, polymerase chain reaction, polymorphism analysis
Keywords
recurrent colon cancer, recurrent rectal cancer
Medical subject headings
Colonic Neoplasms, Rectal Neoplasms

What participants receive

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

  • lenalidomideDrug

    Also called CC-5013, IMiD-1, Revlimid

    Given orally

  • cetuximabBiological

    Also called Anti-EGFR Monoclonal Antibody, C225, C225 monoclonal antibody, IMC-C225

    Given IV

  • mutation analysisOther

    Correlative studies

  • polymerase chain reactionOther

    Also called PCR

    Correlative studies

  • polymorphism analysisGenetic

    Correlative studies

Study groups in NCT01126450
Study groupRoleWhat they receive
Arm IExperimentalPatients receive oral lenalidomide once daily on days 1-28 and cetuximab IV once weekly over 1-2 hours on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Receives: Drug: lenalidomide; Biological: cetuximab; Other: mutation analysis; Other: polymerase chain reaction; Genetic: polymorphism analysis

What is being measured

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

  1. Safety / Tolerability (type, frequency, severity, and relationship of adverse events to study drug)

    Measured: Courses repeat every 28 days in the absence of unacceptable toxicity.

Secondary outcomes (3)

  1. Time to progression of disease

    Measured: Courses repeat every 28 days in the absence of disease progression .

  2. Tumor response according to RECIST

    Measured: at the end of Cycle 2 and every 56 days thereafter until tumor progression

  3. Lab correlatives (FCGRIIa and FCGRIIIa polymorphisms, K-Ras and B-Raf mutations)

    FCGR2a and FCGR3a polymorphisms, K-Ras and B-Raf mutations in patient specimens (paraffin embedded formaldehyde fixed tissues) will be identified.

    Measured: Tissue collection less than or equal to 28 days prior to day 1 of therapy

Timeline

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

  1. First posted19 May 2010 (estimated)
  2. Study startOct 2009
  3. Primary completionNov 2010
  4. Study completionDec 2010

Why it stopped: low accrual,loss of funding and results from EU study showing drug ineffective.

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
3 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01126450
Sponsor's protocol ID
CASE8208
Other IDs
NCI-2010-01202, CASE8208
Status last verified
Mar 2012
First submitted
18 May 2010
Last updated
20 Mar 2012
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing lenalidomide, cetuximab and mutation analysis in people with Colon Cancer and Rectal Cancer, run by Case Comprehensive Cancer Center 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 12 inclusion and 26 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 20 Mar 2012. 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 was stopped early (reason given: low accrual,loss of funding and results from EU study showing drug ineffective.). Results are not available in the source record.

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?

Safety / Tolerability (type, frequency, severity, and relationship of adverse events to study drug) (time frame: Courses repeat every 28 days in the absence of unacceptable toxicity.). 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 NCT01126450.

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 20 Mar 2012.

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