Study in Advanced Solid Tumors

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2015 by Eli Lilly and Company
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01099358
First received: March 30, 2010
Last updated: March 24, 2015
Last verified: March 2015
  Purpose

The primary purpose of this study is to help answer the following research question(s):

  • To see how the body absorbs, processes, and gets rid of cetuximab when the drug is taken in combination with cisplatin [pharmacokinetic (PK) analysis]
  • To see if any drug interactions occur between cetuximab and cisplatin.

Condition Intervention Phase
Solid Tumor
Drug: Cetuximab
Drug: Cisplatin
Drug: 5 - Fluorouracil
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Phase 2 Study to Evaluate the Pharmacokinetics and Drug-Drug Interaction of Cetuximab and Cisplatin in Patients With Advanced Solid Tumors

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Cisplatin pharmacokinetics: Area under the curve (AUC) [ Time Frame: Baseline (prior to Cisplatin infusion); 1, 1:30, 2, 3, 5, 8, 24, 72 hours (after the start of Cisplatin infusion) on Day 1 of weeks 1 (Groups C and D) and 5 (Group C) ] [ Designated as safety issue: No ]
  • Cetuximab pharmacokinetics: Area under the curve (AUC) [ Time Frame: Baseline (prior to Cetuximab infusion); 1, 2, 4, 8, 24, 72, 120, and 168 hours (after the start of Cetuximab infusion) on Day 1 of weeks 4 and 5 (Group C) ] [ Designated as safety issue: No ]
  • Cisplatin pharmacokinetics: Maximum plasma concentration (Cmax) [ Time Frame: Baseline (prior to Cisplatin infusion); 1, 1:30, 2, 3, 5, 8, 24, 72 hours (after the start of Cisplatin infusion) on Day 1 of weeks 1 (Groups C and D) and 5 (Group C) ] [ Designated as safety issue: No ]
  • Cetuximab pharmacokinetics: Maximum plasma concentration (Cmax) [ Time Frame: Baseline (prior to Cetuximab infusion); 1, 2, 4, 8, 24, 72, 120, and 168 hours (after the start of Cetuximab infusion) on Day 1 of weeks 4 and 5 (Group C) ] [ Designated as safety issue: No ]
  • Cisplatin pharmacokinetics: Measurement of the time after administration when the maximum plasma concentration is reached (Tmax) [ Time Frame: Baseline (prior to Cisplatin infusion); 1, 1:30, 2, 3, 5, 8, 24, 72 hours (after the start of Cisplatin infusion) on Day 1 of weeks 1 (Groups C and D) and 5 (Group C) ] [ Designated as safety issue: No ]
  • Cetuximab pharmacokinetics: Measurement of the time after administration when the maximum plasma concentration is reached (Tmax) [ Time Frame: Baseline (prior to Cetuximab infusion); 1, 2, 4, 8, 24, 72, 120, and 168 hours (after the start of Cetuximab infusion) on Day 1 of weeks 4 and 5 (Group C) ] [ Designated as safety issue: No ]
  • Cetuximab pharmacokinetics: Confirmatory serum concentration [ Time Frame: Prior to Cisplatin infusion on Day 1 of week 1 (Group D) ] [ Designated as safety issue: No ]

Estimated Enrollment: 8
Study Start Date: April 2010
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cetuximab and Cisplatin (D)

Cycle 1 (1 week, combination therapy): Cetuximab 400 milligrams per square meter (mg/m^2) on day 1; Cisplatin 100 mg/m^2 on day 1; optional 5- fluorouracil (FU) 1000 mg/ m^2 on day 1-4.

After 1 cycle, participants may continue treatment as determined by the physician until progression of disease, unacceptable toxicity, or another withdrawal criterion is met.

After protocol amendment June 2014, any newly enrolled participants will be placed into Cetuximab and Cisplatin (D) arm only.

Drug: Cetuximab
Administered Intravenously
Drug: Cisplatin
Administered Intravenously
Drug: 5 - Fluorouracil
Administered Intravenously
Experimental: Cetuximab and Cisplatin (C)

Cycle 1 (4 weeks, combination therapy): Week 1 - Cisplatin 100 mg/m^2 on day 1; 5-FU 1000 mg/m^2 on days 1-4. Week 2 - Cetuximab 400 mg/m^2 on day 1. Week 3 - Cetuximab 250 mg/m^2 on day 1. Week 4 - Cetuximab 250 mg/m^2 on day 1.

Cycle 2-6 (3 weeks combination therapy): Week 1 - Cisplatin 100 mg/m^2 on day 1; 5-FU 1000 mg/m^2 on days 1-4; Cetuximab 250 mg/m^2 on day 1. Week 2 - Cetuximab 250 mg/m^2 on day 1. Week 3 - Cetuximab 250 mg/m^2 on day 1.

After 6 cycles, participants may then receive weekly Cetuximab monotherapy until progression of disease, unacceptable toxicity, or another withdrawal criterion is met.

Due to protocol amendment in September 2011, any newly enrolled participants were placed into Cetuximab and Cisplatin (C) arm only. After protocol amendment June 2014, any newly enrolled participants will be placed into Cetuximab and Cisplatin (D) arm only.

Drug: Cetuximab
Administered Intravenously
Drug: Cisplatin
Administered Intravenously
Drug: 5 - Fluorouracil
Administered Intravenously
Experimental: Cetuximab on Cisplatin (B)

Cycle 1: Week 1 - Cisplatin 100 mg/m^2; 5-FU 1000 mg/m^2 on days 1-4 Week 2 - Cetuximab 400 mg/m^2 on day 1 Week 3 - Cetuximab 250 mg/m^2 on day 1.

Cycle 2-6: Week 1 - Cisplatin 100 mg/m^2; 5-FU 1000 mg/m^2 on days 1-4; Cetuximab 250 mg/m^2 on day 1. Week 2 - Cetuximab 250 mg/m^2 on day 1.

Week 3 - Cetuximab 250 mg/m^2 on day 1. After 6 cycles, participants may then receive weekly Cetuximab monotherapy until progression of disease, unacceptable toxicity, or another withdrawal criterion is met.

Due to protocol amendment in September 2011, any newly enrolled participants were placed into Cetuximab and Cisplatin (C) arm only. After protocol amendment June 2014, any newly enrolled participants will be placed into Cetuximab and Cisplatin (D) arm only.

Drug: Cetuximab
Administered Intravenously
Drug: Cisplatin
Administered Intravenously
Drug: 5 - Fluorouracil
Administered Intravenously
Experimental: Cisplatin on Cetuximab (A)

Cycle 1: Week 1 - Cetuximab 400 mg/m^2 on day 1 Week 2 - Cetuximab 250 mg/m^2 on day 1 Week 3 - Cetuximab 250 mg/m^2 on day 1.

Cycle 2-7: Week 1 - Cisplatin 100 mg/m^2; 5-FU 1000 mg/m^2 on days 1-4; Cetuximab 250 mg/m^2 on day 1. Week 2 - Cetuximab 250 mg/m^2 on day 1.

Week 3 - Cetuximab 250 mg/m^2 on day 1. After 7 cycles, participants may then receive weekly Cetuximab monotherapy until progression of disease, unacceptable toxicity, or another withdrawal criterion is met.

Due to protocol amendment in September 2011, any newly enrolled participants were placed into Cetuximab and Cisplatin (C) arm only. After protocol amendment June 2014, any newly enrolled participants will be placed into Cetuximab and Cisplatin (D) arm only.

Drug: Cetuximab
Administered Intravenously
Drug: Cisplatin
Administered Intravenously
Drug: 5 - Fluorouracil
Administered Intravenously

  Eligibility

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

Inclusion Criteria:

  • The participant has histologically or cytologically advanced solid tumor that is resistant to standard therapy or for which there is no standard therapy.
  • The participant has measurable or non-measurable disease.
  • The participant has a life expectancy of greater than 3 months.
  • The participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
  • The participant has adequate hematologic function as defined by absolute neutrophil count greater than or equal to 1500/microliter (μL), hemoglobin greater than or equal to 9 grams/deciliter (g/dL), and platelet count greater than or equal to 100,000/μL.
  • The participant has adequate hepatic function as defined by a total bilirubin less than or equal to 2 x the upper limit of normal (ULN), aspartate transaminase (AST, SGOT) and alanine transaminase (ALT, SGPT) less than or equal to 3 x the ULN (or less than or equal to 5 x the ULN in the presence of known liver metastases).
  • The participant has adequate renal function as defined by serum creatinine less than or equal to 1.5 x the institutional ULN or creatinine clearance greater than or equal to 60 mL/min for participants with creatinine levels above the ULN.
  • The participant has the ability to understand, and the willingness to sign, a written informed consent document.
  • If the participant has received prior therapy with platinum, the time to the first treatment of study drug from the last platinum exposure is >28 days.

Exclusion Criteria:

  • The participant has symptomatic brain or leptomeningeal metastasis.
  • The participant has not recovered from Adverse Events due to agents administered more than 4 weeks earlier. Neurotoxicity, if present, must have improved to Grade less than 2 per the National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) v 3.0.
  • The participant is receiving any other investigational agent(s).
  • The participant is receiving concurrent treatment with other anticancer therapy, including chemotherapy, immunotherapy, hormonal therapy, RT, chemoembolization, or targeted therapy. Participants receiving palliative radiation therapy to bony metastases prior to the first dose of study medication are eligible.
  • The participant is receiving therapy with immunosuppressive agents.
  • The participant has known drug or alcohol abuse.
  • The participant has uncontrolled hypertension defined as systolic blood pressure greater than or equal to 180 millimeters of mercury (mm Hg) or diastolic blood pressure greater than or equal to 130 mm Hg.
  • The participant has a history of allergic reactions attributed to compounds of chemical or biologic composition similar to those of cetuximab or cisplatin.
  • The participant has a medical or psychological condition that would not permit the participant to complete the study or sign informed consent.
  • The participant has clinically relevant coronary artery disease or history of myocardial infarction in the last 12 months or high risk of uncontrolled arrhythmia or uncontrolled cardiac insufficiency.
  • The participant, if female, is pregnant (confirmed by serum or urine beta-human chorionic gonadotropin [β-HCG] pregnancy test) or breastfeeding
  • The participant has had a known positive test result for the human immunodeficiency virus.
  • The participant has an active infection (requiring intravenous [IV] antibiotics), including tuberculosis.
  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: NCT01099358

Contacts
Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559

Locations
United States, Arkansas
Highlands Oncology Group Recruiting
Fayetteville, Arkansas, United States, 72703
Contact    479-587-1700      
Principal Investigator: Joseph Beck         
United States, Nevada
VA Sierra Nevada Health Care System Recruiting
Reno, Nevada, United States, 89502
Contact    775-328-1828      
Principal Investigator: Frederick MacKintosh         
United States, North Carolina
University of North Carolina Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact    919-966-3786      
Principal Investigator: Neil Hayes         
United States, Texas
University of Texas Health Science Center - San Antonio Active, not recruiting
San Antonio, Texas, United States, 78229
Canada, Ontario
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Active, not recruiting
London, Ontario, Canada, N6A 4L6
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Eli Lilly and Company         
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
  More Information

No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01099358     History of Changes
Other Study ID Numbers: 13418, I4E-MC-JXBA
Study First Received: March 30, 2010
Last Updated: March 24, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Eli Lilly and Company:
Cancer of Head and Neck
Cancer of the Head and Neck
Head and Neck Cancer
Cancer of Head
Cancer of Neck
Cancer of the Head
Cancer of the Neck
Head Cancer
Head Neoplasms
Head, Neck Neoplasms
Neck Cancer
Neck Neoplasms
Solid Neoplasm
Carcinoma
Sarcoma

Additional relevant MeSH terms:
Cetuximab
Cisplatin
Antineoplastic Agents
Pharmacologic Actions
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on March 31, 2015