Neoplasms

All Conditions

Rare Diseases

Carcinoma

Head and Neck Neoplasms

Sarcoma

Soft Tissue Sarcoma

Antineoplastic Agents

All Drugs and Chemicals

Cetuximab

Fluorouracil

Cisplatin

Antimetabolites

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Immunological

Cycle 1 (1 week, combination therapy):

400 milligrams per square meter (mg/m²) cetuximab administered (admin) intravenously (I.V) on week 1, day 1.

100 mg/m² cisplatin administered I.V on week 1, day 1. Optional 5- fluorouracil (FU) administered as a 96-hour continuous infusion (C.I.) of 1000 mg/m²/day (d) administered starting on week 1, day 1.

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 February 2014, any newly enrolled participants will be placed into cetuximab and cisplatin (D) arm only.

Cycle 1 (4 weeks, combination therapy):

100 mg/m² Cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 400 mg/m² cetuximab admin I.V on week 2, day 1. 250 mg/m² cetuximab admin I.V on week 3 and 4, day 1.

Cycle 2-6 (3 weeks combination therapy):

100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 250 mg/m² cetuximab admin I.V on week 1, 2, and 3, 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 February 2014, any newly enrolled participants will be placed into cetuximab and cisplatin (D) arm only.

Cycle 1:

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

Cycle 2:

100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1- 4.

250 mg/m² cetuximab admin I.V on week 1-3, day 1.

Cycle 3 + :

100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4.

250 mg/m² cetuximab admin I.V on week 1-3, 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 February 2014, any newly enrolled participants will be placed into cetuximab and cisplatin (D) arm only.

Cycle 1:

100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4.

400 mg/m² cetuximab admin I.V on week 2, day 1. 250 mg/m² cetuximab admin I.V on week 3, day 1.

Cycle 2 +:

100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4.

250 mg/m² cetuximab admin I.V on weeks 1-3, 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 February 2014, any newly enrolled participants will be placed into cetuximab and cisplatin (D) arm only.

5 - Fluorouracil

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

Study in Advanced Solid Tumors

Phase 2 Study to Evaluate the Pharmacokinetics and Drug-Drug Interaction of Cetuximab and Cisplatin 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

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

Cisplatin on Cetuximab (A)

Cycle 1:

100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4.

400 mg/m² cetuximab admin I.V on week 2, day 1. 250 mg/m² cetuximab admin I.V on week 3, day 1.

Cycle 2 +:

100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4.

250 mg/m² cetuximab admin I.V on weeks 1-3, 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 February 2014, any newly enrolled participants will be placed into cetuximab and cisplatin (D) arm only.

Cisplatin on Cetuximab (A)

Cetuximab on Cisplatin (B)

Cycle 1:

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

Cycle 2:

100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1- 4.

250 mg/m² cetuximab admin I.V on week 1-3, day 1.

Cycle 3 + :

100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4.

250 mg/m² cetuximab admin I.V on week 1-3, 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 February 2014, any newly enrolled participants will be placed into cetuximab and cisplatin (D) arm only.

Cetuximab on Cisplatin (B)

Cetuximab and Cisplatin (C)

Cycle 1 (4 weeks, combination therapy):

100 mg/m² Cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 400 mg/m² cetuximab admin I.V on week 2, day 1. 250 mg/m² cetuximab admin I.V on week 3 and 4, day 1.

Cycle 2-6 (3 weeks combination therapy):

100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 250 mg/m² cetuximab admin I.V on week 1, 2, and 3, 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 February 2014, any newly enrolled participants will be placed into cetuximab and cisplatin (D) arm only.

Cetuximab and Cisplatin (C)

Cetuximab and Cisplatin (D)

Cycle 1 (1 week, combination therapy):

400 milligrams per square meter (mg/m²) cetuximab administered (admin) intravenously (I.V) on week 1, day 1.

100 mg/m² cisplatin administered I.V on week 1, day 1. Optional 5- fluorouracil (FU) administered as a 96-hour continuous infusion (C.I.) of 1000 mg/m²/day (d) administered starting on week 1, day 1.

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 February 2014, any newly enrolled participants will be placed into cetuximab and cisplatin (D) arm only.

Cetuximab and Cisplatin (D)

A:Cycle1:100mg/m² cisplatin(cs) I.V on week(w)1,day(d)1. 5-FU as a 96-hour(h) C.I. of 1000 mg/m²/d starting (st) on w 1,d 1-4.

400mg/m² cetuximab(ct) I.V on w 2,d 1.250mg/m² ct I.V on w 3,d 1.Cycle 2+100mg/m² cs I.V on w 1,d 1.5-FU as a 96-h C.I. of 1000mg/m²/d st on w 1,d 1-4.250mg/m² ct I.V on w 1-3,d 1.

B:Cycle1:400mg/m² ct I.V on w 1,d 1.250mg/m² ct I.V on w 2\&3,d 1.Cycle 2:100mg/m² cs I.V on w 1, d 1.5-FU as a 96-h C.I. of 1000mg/m²/d st on w 1,d 1- 4.250mg/m² ct I.V on w 1-3,d 1.Cycle 3 +:100mg/m² cs I.V on w 1,d 1.5-FU as a 96-h C.I. of 1000mg/m²/d st on w 1,d 1-4.

250mg/m² ct I.V on w 1-3,d 1. C:Cycle1:100mg/m² cs I.V on w 1, d 1. 5-FU as a 96-h C.I. of 1000mg/m²/d st on w 1,d 1.400 mg/m² ct I.V on w 2,d 1.250mg/m² ct I.V on w 3\&4,d 1.Cycle2-6:100mg/m² cs I.V on w 1,d 1.5-FU as a 96-h C.I. of 1000mg/m²/d st w 1,d 1. 250mg/m² ct I.V w 1,2,\&3,d 1.

D:Cycle1:400mg/m² ct I.V w 1,d 1.100mg/m² cs I.V w 1,d 1.Optional 5-FU as a 96-h C.I. of 1000mg/m²/d st w 1,d 1.

All Participants (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

Due to protocol amendment in Sep 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.

Chief Medical Officer

Cisplatin on Cetuximab (A)

Cycle 1:

100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4.

400 mg/m² cetuximab admin I.V on week 2, day 1. 250 mg/m² cetuximab admin I.V on week 3, day 1.

Cycle 2 +:

100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4.

250 mg/m² cetuximab admin I.V on weeks 1-3, day 1.

Cetuximab and Cisplatin (C)

Cycle 1 (4 weeks, combination therapy):

100 mg/m² Cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 400 mg/m² cetuximab admin I.V on week 2, day 1. 250 mg/m² cetuximab admin I.V on week 3 and 4, day 1.

Cycle 2-6 (3 weeks combination therapy):

100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 250 mg/m² cetuximab admin I.V on week 1, 2, and 3, day 1.

Cetuximab (A and C)

Cetuximab and Cisplatin (A and C)

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

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

Cetuximab on Cisplatin (B) Cycle 1:400 mg/m² cetuximab admin I.V on week 1, day 1. 250 mg/m² cetuximab admin I.V on week 2 and 3, day 1.

Cycle 2:

100 mg/m² cisplatin admin I.V on week 1, day 1. 5-FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1- 4.

250 mg/m² cetuximab admin I.V on week 1-3, day 1.

Cycle 3 + :

100 mg/m² cisplatin admin I.V on week 1, day 1. 5-FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4.

250 mg/m² cetuximab admin I.V on week 1-3, day 1.

Cetuximab and Cisplatin (C) Cycle 1 100 mg/m² cisplatin admin I.V on week 1, day 1. 5-FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 400 mg/m² cetuximab admin I.V on week 2, day 1. 250 mg/m² cetuximab admin I.V on week 3 and 4, day 1.

Cycle 2-6 100 mg/m² cisplatin admin I.V on week 1, day 1. 5-FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 250 mg/m² cetuximab admin I.V on week 1, 2, and 3, day 1.

Cetuximab (B and C)

Cetuximab and Cisplatin (B and C)

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

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

Total Cisplatin Pharmacokinetics: Maximum Observed Plasma Concentration (Cmax)

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 Group A or Group D.

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

Total Cisplatin Pharmacokinetics: Measurement of the Time After Administration When the Maximum Plasma Concentration is Reached (Tmax)

Cetuximab Pharmacokinetics: Measurement of the Time After Administration When the Maximum Plasma Concentration is Reached (Tmax)

Cetuximab and Cisplatin (D)

Cycle 1 (1 week, combination therapy):

400 milligrams per square meter (mg/m²) cetuximab administered (admin) intravenously (I.V) on week 1, day 1.

100 mg/m² cisplatin administered I.V on week 1, day 1. Optional 5- fluorouracil (FU) administered as a 96-hour continuous infusion (C.I.) of 1000 mg/m²/day (d) administered starting on week 1, day 1.

Cetuximab (D)

All participants who received at least one dose of study drug who were enrolled in Group D and had evaluable PK data.

Cetuximab Pharmacokinetics: Confirmatory Serum Concentration

Cycle 1:

100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4.

400 mg/m² cetuximab admin I.V on week 2, day 1. 250 mg/m² cetuximab admin I.V on week 3, day 1.

Cycle 2 +:

100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4.

250 mg/m² cetuximab admin I.V on weeks 1-3, 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 February 2014, any newly enrolled participants will be placed into cetuximab and cisplatin (D) arm only.

Cycle 1:

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

Cycle 2:

100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1- 4.

250 mg/m² cetuximab admin I.V on week 1-3, day 1.

Cycle 3 + :

100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4.

250 mg/m² cetuximab admin I.V on week 1-3, 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 February 2014, any newly enrolled participants will be placed into cetuximab and cisplatin (D) arm only.

Spots Global Cancer Trial Database for Study in Advanced Solid Tumors

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

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Contact Details

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