A Dose Finding Study of Eribulin Mesylate and Cetuximab For Patients With Advanced Head and Neck and Colon Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Brown University
Sponsor:
Collaborators:
Fatima Memorial Hospital
Montefiore Medical Center
Roger Williams Medical Center
Rhode Island Hospital
The Miriam Hospital
Information provided by (Responsible Party):
howard safran, Brown University
ClinicalTrials.gov Identifier:
NCT01744340
First received: February 23, 2012
Last updated: July 16, 2014
Last verified: July 2014
  Purpose

The purpose of this study is to determine if the full dose of eribulin mesylate can be safely given with the full dose of cetuximab. The activity of the combination of eribulin mesylate and cetuximab on recurrent head and neck cancer and colon cancer will also be assessed.


Condition Intervention Phase
Head and Neck Cancer
Colon Cancer
Drug: Head and neck
Drug: Colon- Closed as of May 2014
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Dose Finding Study of Eribulin Mesylate and Cetuximab For Patients With Advanced Head and Neck and Colon Cancer With an Expansion Cohort For Head and Neck Cancer: A Brown University Oncology Research Group Study

Resource links provided by NLM:


Further study details as provided by Brown University:

Primary Outcome Measures:
  • Toxicity of eribulin mesylate combined with full dose cetuximab for patients with advanced head and neck cancer and colon cancer. [ Time Frame: From beginning of treatment to 30 days post being off drug, an expected average of 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Response rate (whether patient's disease is progressing or being controlled) of patients with head and neck cancer treated with eribulin mesylate and cetuximab. [ Time Frame: From beginning of treatment to progression of disease, for an expected average of 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 63
Study Start Date: May 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: head and neck
Cetuximab, 400 mg/m2 cycle 1 week 1, then 250 mg/m2/weekly there after Eribulin Mesylate 1.4mg/m2
Drug: Head and neck

Eribulin mesylate is administered by IV infusion over 2-5 minutes on day 1 and 8 of a 21 day cycle 1.4mg/m2 and Cetuximab 400 mg/m2 cycle 1 week 1, then 250 mg/m2/weekly thereafter

Dose Level 1: 0.7 mg/m2 IV infusion days 1 and 8 of 21 day cycle Dose Level 2: 1.0 mg/m2 IV infusion days 1 and 8 of 21 day cycle Dose Level 3: 1.4 mg/m2 IV infusion days 1 and 8 of 21 day cycle

Experimental: Colon- closed as of May 2014

Eribulin Mesylate:

1.4 mg/m2 IV infusion days 1 and 8 of 21 day cycle

Drug: Colon- Closed as of May 2014

Eribulin Mesylate:

1.4 mg/m2 IV infusion days 1 and 8 of 21 day cycle


Detailed Description:

To determine if eribulin mesylate, up to a maximum dose of 1.4 mg/m2 day 1 and 8 of a 21 day cycle, can be safely combined with full dose cetuximab for patients with advanced head and neck cancer and colon cancer

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • Histologically or cytologically confirmed advanced squamous cell cancer of the head and neck with progression after at least one prior therapy. (Chemoradiation is considered one line of therapy). Patients with unknown Head and Neck primaries are also eligible
  • In the dose escalation cohorts, patients with advanced colon adenocarcinoma with wild-type kras who have previously received at least two lines of therapy for advanced disease are eligible- No longer applicable post February 2013 as all patients have been enrolled to the dose escalation phase
  • In the expansion phase for patients with advanced colorectal cancer, only patients with mutated kras who have previously received at least two lines of therapy for metastatic disease will be eligible. Pathology report from diagnosis and report documenting KRAS status to be sent to BrUOG. No longer applicable as this phase of the study has been closed as of 5/6/2014 secondary to the lack of efficacy and activity of the single agent.
  • Life expectancy of at least 3 months
  • Patients must be aged 18 years or older
  • Patients with measurable tumors according to RECIST .
  • Patients must have an Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
  • No severe concurrent illness that would interfere with protocol therapy.
  • Patients must have adequate renal function as evidenced by ≤1.5 mg/dL or creatinine clearance > 40 mL/minute (min).
  • Patients must have adequate bone marrow function as evidenced by absolute neutrophil count (ANC) > 1.5 x 109/L and platelet count > 100 x 109/L.
  • Patients must have adequate hepatic function as evidenced by bilirubin ≤ 1.5 times the upper limit of normal (ULN) and alanine aminotransferase (ALT), and aspartate aminotransferase (AST) ≤ 3 x ULN (in the case of liver metastases ALT and AST ≤ 5 x ULN).
  • Resolution of all chemotherapy or radiation-related toxicities to Grade 1 severity or below, except for alopecia.
  • Patients must be willing and able to comply with the study protocol for the duration of the study.
  • Patients must give written informed consent prior to any study-specific screening procedures with the understanding that the patient may withdraw consent at any time without prejudice.
  • No other active invasive malignancy unless disease free for at least 2 years.

Exclusion Criteria

  • For Head and Neck patients, no progression while receiving an EGFR inhibitor or within 6 months of stopping treatment with an EGFR inhibitor.
  • Patients who received chemotherapy or investigational therapy within 3 weeks before treatment initiation. Radiation must be completed within 2 weeks before treatment initiation.
  • Patients with a hypersensitivity to halichondrin B and/or halichondrin B chemical derivative.
  • Patients who participated in a prior eribulin mesylate clinical trial, whether or not they received eribulin mesylate.
  • Patients with other significant disease or disorders that, in the investigator's opinion, would exclude the patient from the study.
  • Women who are pregnant or breast-feeding; women of childbearing potential with either a positive pregnancy test at screening or no pregnancy test; women of childbearing potential unless (1) surgically sterile or (2) using adequate measures of contraception in the opinion of the Investigator. Peri-menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential.
  • Patients with brain or subdural metastases are not eligible, unless they have completed local therapy and have discontinued the use of corticosteroids for this indication for at least 4 weeks before starting treatment in this study. Any signs (e.g., radiologic) and/or symptoms of brain metastases must be stable for at least 4 weeks.
  • Grade 2 or worse neuropathy.
  • Significant cardiovascular impairment (history of congestive heart failure > NYHA G II, unstable angina or myocardial infarction within the past six months, or serious cardiac arrhythmia.
  • QTc > 500 msec
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01744340

Contacts
Contact: Kayla Rosati 401-863-3000 Kayla_rosati@brown.edu

Locations
United States, New York
Montefiore Recruiting
Bronx, New York, United States, 10467
Contact: Kayla rosati    401-863-3000    kayla_rosati@brown.edu   
Principal Investigator: Lakshmi Rajdev, MD         
United States, Rhode Island
Memorial Hospital Recruiting
Pawtucket, Rhode Island, United States, 02860
Contact: Patti Wingate    401-729-2225    patti_wingate@mhri.org   
Principal Investigator: Anthony Thomas, MD         
Rhode Island Hospital Active, not recruiting
Providence, Rhode Island, United States, 02903
The Miriam Hospital Active, not recruiting
Providence, Rhode Island, United States, 02904
Roger Williams Medical Center Not yet recruiting
Providence, Rhode Island, United States, 02908
Contact: Kayla Rosati    401-863-3000    Kayla_rosati@brown.edu   
Principal Investigator: Ritesh Rathore, MD         
Sponsors and Collaborators
howard safran
Fatima Memorial Hospital
Montefiore Medical Center
Roger Williams Medical Center
Rhode Island Hospital
The Miriam Hospital
Investigators
Principal Investigator: Howard Safran, MD Brown University Oncology Research Group
  More Information

No publications provided

Responsible Party: howard safran, Prinicipal Investigator, Brown University
ClinicalTrials.gov Identifier: NCT01744340     History of Changes
Other Study ID Numbers: BrUOG 254
Study First Received: February 23, 2012
Last Updated: July 16, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Brown University:
Head and Neck
Colon

Additional relevant MeSH terms:
Colonic Neoplasms
Head and Neck Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Cetuximab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014