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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


Phase 1
18 Years
N/A
Not Enrolling
Both
Colon Cancer, Rectal Cancer

Thank you

Trial Information

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


PRIMARY OBJECTIVES:

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

SECONDARY OBJECTIVES:

I. 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.

Inclusion Criteria


Inclusion

- 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)

- 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

Exclusion

- 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

- 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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

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

Safety Issue:

Yes

Principal Investigator

Richard Kim

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

CASE8208

NCT ID:

NCT01126450

Start Date:

October 2009

Completion Date:

December 2010

Related Keywords:

  • Colon Cancer
  • Rectal Cancer
  • recurrent colon cancer
  • recurrent rectal cancer
  • Colonic Neoplasms
  • Rectal Neoplasms
  • Colorectal Neoplasms

Name

Location

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer CenterCleveland, Ohio  44195