Neoplasms

All Conditions

Rare Diseases

Carcinoma

Head and Neck Neoplasms

Sarcoma

Soft Tissue Sarcoma

Antineoplastic Agents

All Drugs and Chemicals

Carboplatin

Fluorouracil

Cetuximab

Antineoplastic Agents, Immunological

Group D:

Cycle 1 (1 week, combination therapy):

400 milligrams per square meter (mg/m ²) cetuximab administered intravenously (I.V) on week 1,day 1. Carboplatin area under the curve (AUC=5) administered I.V on week 1,day 1.

Optional 5- fluorouracil (FU) administered as a 96-hour continuous infusion (C.I.) of 1000 mg/ m ²/day administered starting on week 1, day 1.

After 1 cycle, participants may then receive cetuximab as determined by clinical exam or radiological imaging studies until progression of disease, unacceptable toxicity, or another withdrawal criterion is met.

After protocol amendment February 2014, any newly enrolled participants were placed into Group D only.

Group C: Cycle 1 (4 weeks, combination therapy): Carboplatin (AUC=5) administered I.V on week 1, day 1.1000 mg/m ²/day 5-FU administered as a 96-hour C.I. starting on week 1, day 1.

400 mg/m² cetuximab administered I.V on week 2, day 1. 250 mg/m ² cetuximab administered I.V on week 3 and 4, day 1.

Cycle 2-6 (3 weeks, combination therapy): Carboplatin (AUC=5) administered I.V on week1,day1.1000 mg/m ²/d 5-FU as a 96-hour C.I. starting on week1, day1. 250 mg/m ² cetuximab administered I.V on Week 1-3, day 1.

After 6 cycles, participants may then receive 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 carboplatin (C) arm only. After protocol amendment February 2014, any newly enrolled participants will be placed into Group D arm only.

Group B:

Cycle 1 (3 weeks, single-agent cetuximab):

400 mg/m² cetuximab administered I.V on week 1, day 1. 250 mg/m ² cetuximab administered I.V on weeks 2 and 3, day 1.

Cycle 2 (3 weeks, combination therapy):

Carboplatin (AUC=5) administered I.V week 1, day 1. 1000 mg/m ²/d 5-FU administered as a 96-hour C.I. starting on week 1, day 1. 250 mg/m ² cetuximab administered I.V weeks 1- 3,day 1.

After 6 cycles, participants may then receive 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 carboplatin (C) arm only. After protocol amendment February 2014, any newly enrolled participants will be placed into Group D arm only.

Group A:

Cycle 1 (3 weeks, combination therapy):

Carboplatin (AUC=5) administered I.V on week 1, day 1. 1000 mg/m ²/d 5-FU administered as a 96-hour C.I. starting on week 1, day 1.

400 mg/m ² cetuximab administered I.V on week 2, day 1. 250 mg/m ² cetuximab administered I.V on week 3, day 1.

Cycle 2 (3 weeks, combination therapy):

Carboplatin (AUC=5) administered I.V on week 1, day 1. 1000 mg/m ²/d 5-FU administered as a 96-hour C.I. starting on week 1, day 1. 250 mg/m ² cetuximab administered I.V on weeks 1- 3, day 1.

After 7 cycles, participants may then receive 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 carboplatin (C) arm only. After protocol amendment February 2014, any newly enrolled participants will be placed into Group D arm only.

5 - FU

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

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 carboplatin \[pharmacokinetic (PK) analysis\]
* To see if any drug interactions occur between cetuximab and carboplatin.

A Study in Advanced Solid Tumors

Phase 2 Study to Evaluate the Pharmacokinetics and Drug-Drug Interaction of Cetuximab and Carboplatin in Patients With Advanced Solid Tumors

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Eli Lilly and Company

Group A:

Cycle 1 (3 weeks, combination therapy):

Carboplatin (AUC=5) administered I.V on week 1, day 1. 1000 mg/m ²/d 5-FU administered as a 96-hour C.I. starting on week 1, day 1.

400 mg/m ² cetuximab administered I.V on week 2, day 1. 250 mg/m ² cetuximab administered I.V on week 3, day 1.

Cycle 2 (3 weeks, combination therapy):

Carboplatin (AUC=5) administered I.V on week 1, day 1. 1000 mg/m ²/d 5-FU administered as a 96-hour C.I. starting on week 1, day 1. 250 mg/m ² cetuximab administered I.V on weeks 1- 3, day 1.

Carboplatin and Cetuximab (A)

Group B:

Cycle 1 (3 weeks, single-agent cetuximab):

400 mg/m² cetuximab administered I.V on week 1, day 1. 250 mg/m ² cetuximab administered I.V on weeks 2 and 3, day 1.

Cycle 2 (3 weeks, combination therapy):

Carboplatin (AUC=5) administered I.V week 1, day 1. 1000 mg/m ²/d 5-FU administered as a 96-hour C.I. starting on week 1, day 1. 250 mg/m ² cetuximab administered I.V weeks 1- 3,day 1.

Carboplatin and Cetuximab (B)

Group C:

Cycle 1 (4 weeks, combination therapy):

Carboplatin (AUC=5) administered I.V on week 1, day 1.1000 mg/m ²/day 5-FU administered as a 96-hour C.I. starting on week 1, day 1.

400 mg/m² cetuximab administered I.V on week 2, day 1. 250 mg/m ² cetuximab administered I.V on week 3 and 4, day1.

Cycle 2-6 (3 weeks, combination therapy):

Carboplatin (AUC=5) administered I.V on week1,day1.1000 mg/m ²/d 5-FU as a 96-hour C.I. starting on week1, day1. 250 mg/m ² cetuximab administered I.V on Week 1-3, day 1.

Carboplatin and Cetuximab (C)

Group D:

Cycle 1 (1 week, combination therapy):

400 milligrams per square meter (mg/m ²) cetuximab administered intravenously (I.V) on day 1. Carboplatin area under the curve (AUC=5) administered I.V on day 1.

Optional 5- fluorouracil (FU) administered as a 96-hour continuous infusion (C.I.) of 1000 mg/ m ²/day administered starting on day 1.

Carboplatin and Cetuximab (D)

Group D:

Cycle 1:400 mg/m² cetuximab week (w) 1,day(d) 1.Carboplatin(AUC=5) on w 1, d 1.Optional 1000 mg/m²/d 5-FU given as a 96-hour C.I. starting(strt) on w 1, d 1.

Group C:

Cycle 1:Carboplatin(AUC=5) on w 1,d 1. 400 mg/m² cetuximab on w 2, d 1.Cetuximab 250 mg/m ² on w 3 and 4, d 1.

Cycle 2-6:Carboplatin(AUC=5) and 250 mg/m² cetuximab on w 1, d 1.1000 mg/m²/d 5-FU given as a 96-hour C.I. strt on w 1, d 1.250 mg/m² cetuximab on w 2 and 3, d 1.

Group B:

Cycle 1:400 mg/m² cetuximab on w 1, d 1. 250 mg/m ² cetuximab on w 2 and 3, d 1.

Cycle 2:Carboplatin(AUC=5) w 1, d 1.1000 mg/m ²/d 5-FU given as 96-hour C.I. strt on w 1, d 1. 250 mg/m ² cetuximab w 1- 3, d 1.

Group A:

Cycle 1:Carboplatin(AUC=5) on w 1, d 1. 1000 mg/m²/d 5-FU given as 96-hour C.I. strt on w 1, d 1.

400 mg/m² cetuximab on w 2, d 1 and 250 mg/m² cetuximab on w 3, d 1. Cycle 2:Carboplatin(AUC=5) given I.V on w 1, d 1.1000 mg/m²/d 5-FU given as 96-hour C.I. strt on w 1, d 1. 250 mg/m² cetuximab on w 1-3, d 1.

All Participants (Group A, B, C and D)

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Canada

United States

Region of Enrollment

All participants who received at least one dose of study drug.

Due to protocol amendment in September 2011, any newly enrolled participants were placed into cetuximab and carboplatin(C) arm only. After protocol amendment February 2014, any newly enrolled participants were placed into Group D arm only.

Chief Medical Officer

Group D:

Cycle 1 (1 week, combination therapy):

400 milligrams per square meter (mg/m ²) cetuximab administered intravenously (I.V) on week 1, day 1. Carboplatin area under the curve (AUC=5) administered I.V on week 1, day 1.

Optional 5- fluorouracil (FU) administered as a 96-hour continuous infusion (C.I.) of 1000 mg/ m ²/day administered starting on week 1, day 1.

Cetuximab and Carboplatin (D)

Participants who received at least 1 dose of study drug who were enrolled in Group(Grp)D \& had evaluable PK data.Study design by intent did not collect data from Grp B.Due to participant recruitment \& retention challenges,there were no PK study completers for Grp A \& C.Participant recruitment \& retention addressed by amending protocol to add Grp D.

Total Carboplatin Pharmacokinetics (PK): Area Under the Concentration (AUC) Versus Time Curve From Time Zero to Infinity (AUC[0-∞])

Group B:

Cycle 1 (3 weeks, single-agent cetuximab):

400 mg/m² cetuximab administered I.V on week 1, day 1. 250 mg/m ² cetuximab administered I.V on weeks 2 and 3, day 1.

Cycle 2 (3 weeks, combination therapy):

Carboplatin (AUC=5) administered I.V week 1, day 1. 1000 mg/m ²/d 5-FU administered as a 96-hour C.I. starting on week 1, day 1. 250 mg/m ² cetuximab administered I.V weeks 1- 3,day 1.

Group C:

Cycle 1 (4 weeks, combination therapy):

Carboplatin (AUC=5) administered I.V on week 1, day 1.1000 mg/m ²/day 5-FU administered as a 96-hour C.I. starting on week 1, day 1.

400 mg/m² cetuximab administered I.V on week 2, day 1. 250 mg/m ² cetuximab administered I.V on week 3 and 4, day 1.

Cycle 2-6 (3 weeks, combination therapy):

Carboplatin (AUC=5) administered I.V on week1,day1.1000 mg/m ²/d 5-FU as a 96-hour C.I. starting on week1, day1. 250 mg/m ² cetuximab administered I.V on Week 1-3, day 1.

Cetuximab (B and C)

Cetuximab and Carboplatin (B and C)

All participants who received at least one dose of study drug who were enrolled in Group B and C and had evaluable PK data. Study design by intent did not collect data from Groups D and A.

Cetuximab PK: Area Under the Concentration Versus Time Curve During One Dosing Interval at Steady State (AUC τ,ss)

Total Carboplatin PK: Maximum Observed Plasma Concentration (Cmax)

Cetuximab PK: Maximum Observed Plasma Concentration at Steady State (Cmax,ss)

Total Carboplatin PK: Time of Maximum Observed Plasma Concentration (Tmax)

Cetuximab PK: Time of Maximum Observed Plasma Concentration at Steady State (Tmax,ss)

Cetuximab (D)

All participants who received at least one dose of study drug who were enrolled in Group D and had evaluable PK data. Study design by intent did not collect data from Groups A, B, and C.

Cetuximab PK: Confirmatory Serum Concentration

Group A:

Cycle 1 (3 weeks, combination therapy):

Carboplatin (AUC=5) administered I.V on week 1, day 1. 1000 mg/m ²/d 5-FU administered as a 96-hour C.I. starting on week 1, day 1.

400 milligrams per square meter (mg/m ²) cetuximab administered I.V on week 2, day 1. 250 mg/m ² cetuximab administered I.V on week 3, day 1.

Cycle 2 (3 weeks, combination therapy):

Carboplatin (AUC=5) administered I.V on week 1, day 1. 1000 mg/m ²/d 5-FU administered as a 96-hour C.I. starting on week 1, day 1. 250 mg/m ² cetuximab administered I.V on weeks 1- 3, day 1.

Cetuximab and Carboplatin (B)

Group C:

Cycle 1 (4 weeks, combination therapy):

Carboplatin (AUC=5) administered I.V on week 1, day 1.1000 mg/m ²/day 5-FU administered as a 96-hour C.I. starting on week 1, day 1.

400 mg/m² cetuximab administered I.V on week 2, day 1. 250 mg/m ² cetuximab administered I.V on week 3 and 4, day 1.

Cycle 2-6 (3 weeks, combination therapy):

Carboplatin (AUC=5) administered I.V on week1,day1.1000 mg/m ²/d 5-FU as a 96-hour C.I. starting on week1, day1. 250 mg/m ² cetuximab administered I.V on Week 1-3, day 1.

Cetuximab and Carboplatin (C)

Cycle 1 (1 week, combination therapy):

400 milligrams per square meter (mg/m ²) cetuximab administered intravenously (I.V) on week 1, day 1. Carboplatin area under the curve (AUC=5) administered I.V on week 1, day 1.

Optional 5- fluorouracil (FU) administered as a 96-hour continuous infusion (C.I.) of 1000 mg/ m ²/day administered starting on week 1, day 1.

Spots Global Cancer Trial Database for A Study in Advanced Solid Tumors

Trial Identification

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Study Description

Keywords

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