A Phase 2 interventional study of Cetuximab and Cisplatin/Carboplatin in Squamous Cell Carcinoma of the Head and Neck, sponsored by Merck KGaA, Darmstadt, Germany. Completed at 10 sites in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2014-04-08.
Sponsored by Merck KGaA, Darmstadt, Germany · Phase 2, Interventional, and Treatment
The primary objective of this trial is to assess the antitumor activity of cetuximab when given in combination with cisplatin + 5-Fluorouracil (5-FU) for the first-line treatment of recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN) in Japanese subjects.
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's enrollment of 33 is below the median of 45 across 5,170 interventional studies indexed under Carcinoma.
Browse Carcinoma studies →Merck KGaA, Darmstadt, Germany is the lead sponsor of 269 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Drug: Cetuximab · Drug: Cisplatin/Carboplatin · Drug: 5-Fluorouracil
The initial dose of cetuximab will be 400 milligram per square meter (mg/m\^2) as an intravenous (IV) infusion over 120 minutes. Subsequent weekly doses will be 250 mg/m\^2 as an IV infusion over 60 minutes.
Subjects will receive 100 mg/m\^2 cisplatin as an IV infusion over 60 minutes on day 1 of each 3-week treatment cycle. If subject developed non-hematological toxicities to cisplatin, carboplatin (area under curve 5 \[AUC5\]) will be administered as an IV infusion over 60 to 120 minutes on Day 1 of each 3-week treatment cycle.
Subjects will receive 1000 mg/m\^2 per day 5-FU as a continuous IV infusion over 24 hours from day 1 to day 4 of each 3-week treatment cycle.
Best Overall Response (BOR) According to Modified World Health Organization (WHO) Criteria
Percentage of participants experiencing a complete response \[CR\] (complete disappearance of measurable and evaluable disease without new lesions) or partial response \[PR\] (greater than or equal to 50 percent decrease in the sum of the products of diameters \[SOPD\] of index lesions compared to the baseline SOPD, with no evidence of PD) confirmed by a subsequent assessment no less than 28 days after criteria for response were first met based on modified WHO criteria as assessed by Independent Review Committee (IRC).
Time frame: Evaluations performed every 6 weeks until progressive disease (PD) reported between day of first participant treated, until cut-off date, 02 March 2011
Best Overall Response (BOR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Criteria
Percentage of participants with objective response based assessment of confirmed CR or confirmed PR according to RECIST as assessed by IRC. CR are those that persist on repeat imaging study at least 28 days after initial documentation of response. PR are those with greater than or equal to 30 percent decrease in the SOPD of index lesions compared to the baseline SOPD, with no evidence of PD.
Time frame: Evaluations performed every 6 weeks until PD reported between day of first participant treated, until cut-off date, 02 March 2011
Disease Control Rate
Percentage of participants experiencing a CR (complete disappearance of measurable and evaluable disease without new lesions) or PR (\>=50 percent decrease in sum of the products of diameters \[SOPD\] of index lesions compared to baseline SOPD, with no evidence of PD) confirmed by subsequent assessment no less than 28 days after criteria for response were first met) or stable disease \[SD\] (neither sufficient decrease to qualify for PR nor sufficient increase to qualify for PD) at least once no less than 42 days after first dose of trial treatment based on modified WHO criteria as assessed by IRC.
Time frame: Evaluations performed every 6 weeks until PD reported between day of first participant treated, until cut-off date, 02 March 2011
Duration of Response
Duration of response according to modified WHO criteria as assessed by IRC was defined as the time from the first assessment of CR or PR until the date of the first occurrence of PD, or until the date of death when death occurred within 60 days of the last tumor assessment or first administration of trial treatment (whichever was last).
Time frame: Time from first assessment of CR or PR to PD, death or last tumor assessment, reported between day of first participant treated, until cut-off date, 02 March 2011
Progression-Free Survival (PFS) Time
The PFS time according to modified WHO criteria as assessed by IRC was defined as duration from first administration of trial treatment until PD (radiological or clinical, if radiological progression is not available) or death due to any cause. Only deaths within 60 days of last tumor assessment are considered. Participants without event are censored on the date of last tumor assessment.
Time frame: Time from first administration of trial treatment to PD, death or last tumor assessment, reported between day of first participant treated, until cut-off date, 02 March 2011
Overall Survival (OS) Time
Time from first administration of trial treatment to death. Participants without event are censored at the last date known to be alive or at the clinical cut-off date, whatever is earlier.
Time frame: Time from first administration of trial treatment or last day known to be alive, reported between day of first participant treated, until cut-off date, 02 March 2011
Time to Treatment Failure
Time to treatment failure according to modified WHO criteria as assessed by IRC was defined as the time from first administration of trial treatment until the date of the first occurrence of one of the events defining treatment failure: PD assessed by the investigator, discontinuation of treatment due to PD, discontinuation of treatment due to an adverse event (AE), start of any new anticancer therapy, or withdrawal of consent or death within 60 days of the last tumor assessment or first administration of trial treatment.
Time frame: Time from first administration of trial treatment to treatment failure or last tumor assessment, reported between day of first participant treated, until cut-off date, 02 March 2011
| Milestone | Cetuximab + Cisplatin/Carboplatin + 5-Fluorouracil (5-FU) |
|---|---|
| Started | 33 |
| Completed | 26 |
| Not completed | 7 |
| Withdrew: Withdrawal by subject | 1 |
| Withdrew: Investigator's decision | 2 |
| Withdrew: Ongoing | 4 |
Percentage of participants experiencing a complete response \[CR\] (complete disappearance of measurable and evaluable disease without new lesions) or partial response \[PR\] (greater than or equal to 50 percent decrease in the sum of the products of diameters \[SOPD\] of index lesions compared to the baseline SOPD, with no evidence of PD) confirmed by a subsequent assessment no less than 28 days after criteria for response were first met based on modified WHO criteria as assessed by Independent Review Committee (IRC).
| percentage of participants | Cetuximab + Cisplatin/Carboplatin + 5-Fluorouracil (5-FU) |
|---|---|
| Best Overall Response (BOR) According to Modified World Health Organization (WHO) Criteria | 36.4 (20.4 to 54.9) |
Percentage of participants with objective response based assessment of confirmed CR or confirmed PR according to RECIST as assessed by IRC. CR are those that persist on repeat imaging study at least 28 days after initial documentation of response. PR are those with greater than or equal to 30 percent decrease in the SOPD of index lesions compared to the baseline SOPD, with no evidence of PD.
| percentage of participants | Cetuximab + Cisplatin/Carboplatin + 5-Fluorouracil (5-FU) |
|---|---|
| Best Overall Response (BOR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Criteria | 45.5 (28.1 to 63.6) |
Percentage of participants experiencing a CR (complete disappearance of measurable and evaluable disease without new lesions) or PR (\>=50 percent decrease in sum of the products of diameters \[SOPD\] of index lesions compared to baseline SOPD, with no evidence of PD) confirmed by subsequent assessment no less than 28 days after criteria for response were first met) or stable disease \[SD\] (neither sufficient decrease to qualify for PR nor sufficient increase to qualify for PD) at least once no less than 42 days after first dose of trial treatment based on modified WHO criteria as assessed by IRC.
| percentage of participants | Cetuximab + Cisplatin/Carboplatin + 5-Fluorouracil (5-FU) |
|---|---|
| Disease Control Rate | 87.9 (71.8 to 96.6) |
Duration of response according to modified WHO criteria as assessed by IRC was defined as the time from the first assessment of CR or PR until the date of the first occurrence of PD, or until the date of death when death occurred within 60 days of the last tumor assessment or first administration of trial treatment (whichever was last).
| months | Cetuximab + Cisplatin/Carboplatin + 5-Fluorouracil (5-FU) |
|---|---|
| Duration of Response | 2.8 (2.8 to 5.5) |
The PFS time according to modified WHO criteria as assessed by IRC was defined as duration from first administration of trial treatment until PD (radiological or clinical, if radiological progression is not available) or death due to any cause. Only deaths within 60 days of last tumor assessment are considered. Participants without event are censored on the date of last tumor assessment.
| months | Cetuximab + Cisplatin/Carboplatin + 5-Fluorouracil (5-FU) |
|---|---|
| Progression-Free Survival (PFS) Time | 4.1 (4.0 to 5.5) |
Time from first administration of trial treatment to death. Participants without event are censored at the last date known to be alive or at the clinical cut-off date, whatever is earlier.
| months | Cetuximab + Cisplatin/Carboplatin + 5-Fluorouracil (5-FU) |
|---|---|
| Overall Survival (OS) Time | 12.8 (8.7 to NA) |
Time to treatment failure according to modified WHO criteria as assessed by IRC was defined as the time from first administration of trial treatment until the date of the first occurrence of one of the events defining treatment failure: PD assessed by the investigator, discontinuation of treatment due to PD, discontinuation of treatment due to an adverse event (AE), start of any new anticancer therapy, or withdrawal of consent or death within 60 days of the last tumor assessment or first administration of trial treatment.
| months | Cetuximab + Cisplatin/Carboplatin + 5-Fluorouracil (5-FU) |
|---|---|
| Time to Treatment Failure | 4.2 (4.1 to 5.6) |
Collected over Baseline until 30 days after last trial treatment.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cetuximab + Cisplatin/Carboplatin + 5-Fluorouracil (5-FU) | — | 12/33 (36.4%) | 33/33 (100%) |
| Event | Cetuximab + Cisplatin/Carboplatin + 5-Fluorouracil (5-FU) |
|---|---|
| Intracardiac massCardiac disorders | 1/33 |
| DiarrheaGastrointestinal disorders | 1/33 |
| DysphagiaGastrointestinal disorders | 1/33 |
| Mechanical ileusGastrointestinal disorders | 1/33 |
| Esophageal fistulaGastrointestinal disorders | 1/33 |
| Septic shockInfections and infestations | 1/33 |
| Staphylococcal sepsisInfections and infestations | 1/33 |
| C-reactive protein increasedInvestigations | 1/33 |
| Decreased appetiteMetabolism and nutrition disorders | 1/33 |
| DehydrationMetabolism and nutrition disorders | 1/33 |
| Event | Cetuximab + Cisplatin/Carboplatin + 5-Fluorouracil (5-FU) |
|---|---|
| Decreased appetiteMetabolism and nutrition disorders | 30/33 |
| LeukopeniaBlood and lymphatic system disorders | 28/33 |
| NeutropeniaBlood and lymphatic system disorders | 27/33 |
| HypomagnesemiaMetabolism and nutrition disorders | 27/33 |
| StomatitisGastrointestinal disorders | 26/33 |
| Dry skinSkin and subcutaneous tissue disorders | 23/33 |
| NauseaGastrointestinal disorders | 23/33 |
| ConstipationGastrointestinal disorders | 22/33 |
| AcneSkin and subcutaneous tissue disorders | 21/33 |
| ThrombocytopeniaBlood and lymphatic system disorders | 20/33 |
| Age, Continuous(years) | Cetuximab + Cisplatin/Carboplatin + 5-Fluorouracil (5-FU) |
|---|---|
| Mean | 57.20 ± 11.42 |
| Sex: Female, Male(Participants) | Cetuximab + Cisplatin/Carboplatin + 5-Fluorouracil (5-FU) |
|---|---|
| Female | 3 |
| Male | 30 |
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Merck KGaA, Darmstadt, Germany