Neoplasms

All Conditions

Carcinoma

Carcinoma, Squamous Cell

Head and Neck Neoplasms

Squamous Cell Carcinoma of Head and Neck

Antineoplastic Agents

All Drugs and Chemicals

Docetaxel

Cetuximab

Fluorouracil

Cisplatin

Tubulin Modulators

Antimitotic Agents

Antimetabolites

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Immunological

docetaxel 75 mg/m2 I.V. day 1, cisplatin 75 mg/m2 I.V. day 1, 5-fluorouracil 750 mg/m2 I.V. continuous infusion days 1-5 repeated every 21 days for 4 cycles

docetaxel, cisplatin, 5-fluorouracil

Three-dimensional conformal radiotherapy planning and delivery (35x2 Gy/day over 7 weeks - weeks 14 - 20 of the study protocol

radiotherapy

* cetuximab 400 mg/m2 I.V. week 13, cetuximab 250 mg/m2 I.V. weeks 14-20
* cisplatin 30 mg/m2 I.V. weeks 14-20 (concomitantly with radiothrapy)

cetuximab, cisplatin

Primož Strojan, MD

The purpose of this study is to determine the efficacy and toxicity of docetaxel/cisplatin/5-fluorouracil induction chemotherapy (4 cycles) followed by concomitant chemoradiation with cetuximab and weekly cisplatin in patients with inoperable squamous cell carcinoma of the head and neck.

The treatment results with radiotherapy in inoperable squamous cell carcinoma of the head and neck are poor.

In this proposed single-institution non-randomized, one-arm, open label phase II study, the authors will test the efficacy and toxicity of docetaxel/cisplatin/5-fluorouracil induction chemotherapy (4 cycles) followed by concomitant chemoradiation with cetuximab and weekly cisplatin in patients with inoperable squamous cell carcinoma of the head and neck.

Chemotherapy doses will be as follows: docetaxel 75 mg/m2 I.V. day 1, cisplatin 75 mg/m2 I.V. day 1, 5-fluorouracil 750 mg/m2 I.V. continuous infusion days 1-5 repeated every 21 days for 4 cycles followed by cetuximab 400 mg/m2 I.V. week 13, cetuximab 250 mg/m2 I.V. weeks 14-20, cisplatin 30 mg/m2 I.V. weeks 14-20. Three-dimensional conformal radiotherapy planning and delivery (35x2 Gy/day over 7 weeks {weeks 14 - 20}) will be used.

The planned number of patients to be included is 30 and anticipated enrolment period is 12 months.

The primary objective of the study is to determine locoregional control at 2 years post-therapy, whereas secondary objectives are to determine feasibility (toxicity profile) of the proposed regimen, to determine complete response rate after induction ChT as well as 14-16 weeks after the therapy, completion of ChRT to determine disease free survival at 2 years, overall survival at 2 years and late toxicity including thyroid function.

Given the preliminary nature of the study, no stopping rule is prospectively planned outside of observed toxicity, which will be assessed and graded according to Common Terminology Criteria for Adverse Events version 3.0.

Induction Chemotherapy Followed by Chemoradiation With Cetuximab in Head and Neck Cancer

Induction Chemotherapy Followed by Chemoradiation With Cetuximab and Cisplatin for Inoperable Squamous Cell Carcinoma of the Head and Neck

Institute of Oncology Ljubljana

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Estrogens

Mitogens

Progesterone

Subjects will receive an initial dose of cetuximab 400 milligram per square meter (mg/m\^2) followed by weekly doses of 250 mg/m\^2. All doses will be given by intravenous (IV) infusion.

Subjects will receive cisplatin (75 mg/m\^2 IV on Day 1) every 3 weeks, with a maximum of 6 cycles.

Administration of the Investigational Medicinal Product (IMP) will be stopped upon the first occurrence of disease progression, unacceptable toxicity or withdrawal of consent.

Subjects will receive cisplatin (75 mg/m\^2 IV on Day 1) every 3 weeks, with a maximum of 6 cycles.

Subjects have the option of receiving cetuximab plus cisplatin at progression within the first 6 cycles, or cetuximab alone at progression after the 6 cycles.

Administration of the IMP will be stopped upon the first occurrence of disease progression (except in cisplatin arm where switch to cetuximab plus cisplatin, or cetuximab alone is possible), unacceptable toxicity or withdrawal of consent.

cisplatin

José Baselga, Prof.

The primary objective of this study is to determine whether overall response to cetuximab combined with cisplatin is better than overall response to cisplatin alone together with showing that the overall response for cetuximab and cisplatin was above a pre-specified threshold of 0.2 in the treatment of "triple negative" metastatic breast cancer.

The secondary objective of this study is to compare the differences between the two treatment groups using the following criteria : Progression-Free Survival (PFS) Time, Overall Survival (OS), Time to Response (TTR) and Safety.

Cetuximab and Cisplatin in the Treatment of "Triple Negative" (Estrogen Receptor [ER] Negative, Progesterone Receptor [PgR] Negative, and Human Epidermal Growth Factor Receptor 2 [HER2] Negative) Metastatic Breast Cancer

Randomized Phase II Trial With Cetuximab and Cisplatin in the Treatment of ER-negative, PgR-negative, HER2-negative Metastatic Breast Carcinoma ("Basal Like")

Percentage of participants with best overall (objective) response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST).

The PFS was defined as the duration from randomization until radiological progression according to investigator (based on RECIST) or death due to any cause. Only deaths within 85 days of last tumor assessment were considered. Participants without event were censored on the date of last tumor assessment.

The OS time was defined as the time from randomization to death. Participants without event were censored at the last date known to be alive or at the clinical cut-off date, whatever was earlier.

The TTR was determined for participants whose confirmed BOR (based on RECIST) was either a CR or a PR . It was defined as the time from the first dose study treatment until the date of the first assessment of confirmed CR or PR.

Number of participants experiencing any AE. AEs: Any untoward medical occurrence in the form of signs, clinically significant abnormalities in laboratory findings, diseases, symptoms, or worsening of complications.

Merck KGaA, Darmstadt, Germany

An AE was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an IMP, regardless of causal relationship.

Cisplatin 75 milligram per square meter (mg/m\^2) intravenous (IV) infusion administered on Day 1 until every 3 weeks with a maximum of 6 cycles and cetuximab initially 400 mg/m\^2 followed by 250 mg/m\^2 IV infusion weekly.

Cisplatin and Cetuximab

Cisplatin 75 mg/m\^2 IV infusion administered on Day 1 until every 3 weeks with a maximum of 6 cycles until the first occurrence of progressive disease (PD), unacceptable toxicity or withdrawal of consent.

On progression, participants in the cisplatin group had the option to switch to cisplatin (75 mg/m\^2 IV infusion) plus cetuximab (initially 400 mg/m\^2 followed by 250 mg/m\^2 IV infusion) if the progressive disease was reported during the 6 cisplatin cycles or to cetuximab alone (initially 400 mg/m\^2 followed by 250 mg/m\^2 IV infusion) if the progression was reported after the 6 cisplatin cycles.

Cisplatin Alone Switched to Cetuximab

Cisplatin 75 milligram per square meter (mg/m\^2) intravenous (IV) infusion administered on Day 1 until every 3 weeks with a maximum of 6 cycles and cetuximab initially 400 mg/m\^2 followed by 250 mg/m\^2 IV infusion weekly. Participants who demonstrated at least stable disease (SD) up to 6 cycles of cisplatin continued treatment with cetuximab only until progressive disease (PD) or occurrence of unacceptable toxicity.

Cisplatin 75 mg/m\^2 IV infusion administered on Day 1 until every 3 weeks with a maximum of 6 cycles until the first occurrence of PD, unacceptable toxicity or withdrawal of consent.

Total

Age, Continuous

< 65 years

>= 65 years

Age, Customized

Sex: Female, Male

Naturally post menopausal participants

Number of participants analyzed "N" are 110 and 56 for each arm group respectively for this specific parameter.

Duration of breast cancer from primary tumor diagnosis to informed consent

Lung

Lymph nodes (by medical review)

Bone

Liver

Skin

Other

A participant can have more than one site of metastasis.

Participants categorized by site of metastasis

Number of participants analyzed "N" are 113 and 56 for each arm group respectively for this specific parameter.

Duration of metastatic breast cancer from metastasis to informed consent

Number of participants analyzed "N" are 108 and 55 for each arm group respectively for this specific parameter.

Duration from initial breast cancer diagnosis to date of metastasis

Participants were randomized to 2 groups in a 2:1 ratio.

Merck KGaA Communication Center

FAS population included all participants who were randomized as described in the pre-assignment details.

Best Overall Response (BOR)

Progression-Free Survival (PFS) Time

Overall Survival (OS) Time

Time to Response (TTR)

Safety population included all the participants who received at least 1 dose of study medication (that is cisplatin or cetuximab).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Induction Chemotherapy Followed by Chemoradiation With Cetuximab in Head and Neck Cancer	NCT00868491	Head and Neck C...	docetaxel, cisp... radiotherapy cetuximab, cisp...	18 Years -	Institute of Oncology Ljubljana
Cetuximab and Cisplatin in the Treatment of "Triple Negative" (Estrogen Receptor [ER] Negative, Progesterone Receptor [PgR] Negative, and Human Epidermal Growth Factor Receptor 2 [HER2] Negative) Metastatic Breast Cancer	NCT00463788	Breast Neoplasm	cetuximab, cisp... cisplatin	18 Years -	Merck KGaA, Darmstadt, Germany

Spots Global Cancer Trial Database for cetuximab, cisplatin