A Randomized Phase 3 Study of Pemetrexed in Combination with Cisplatin Versus Cisplatin Monotherapy in Patients with Recurrent or Metastatic Head and Neck Cancer - ND

• Register: EUCTR
• Last refreshed on: 24 April 2012
• Main ID: EUCTR2006-003158-12-IT
• Date of registration: 16/02/2007
• Prospective Registration: No
• Primary sponsor: Eli Lilly and Company Limited, Erl Wood Manor
• Public title: A Randomized Phase 3 Study of Pemetrexed in Combination with Cisplatin Versus Cisplatin Monotherapy in Patients with Recurrent or Metastatic Head and Neck Cancer - ND
• Scientific title: A Randomized Phase 3 Study of Pemetrexed in Combination with Cisplatin Versus Cisplatin Monotherapy in Patients with Recurrent or Metastatic Head and Neck Cancer - ND
• Date of first enrolment: 05/12/2006
• Target sample size: 790
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-003158-12
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: yes Other specify the comparator: Placebo Cisplatino

Countries of recruitment

France, Germany, Hungary, Italy, Netherlands, Spain

Key inclusion & exclusion criteria

Inclusion criteria:
1 Histologic or cytologic diagnosis of squamous cell HNC, either recurrent disease locally advanced or metastatic that is not amenable to local therapy, i with at least 6 months since completion of surgery, radiation, and/or systemic therapy chemotherapy or biological anticancer therapy , and ii with no more than 1 prior radiation regimen for primary HNC tumor, and iii with no prior systemic therapy chemotherapy or biological anticancer therapy for metastatic disease; OR newly diagnosed distant metastatic disease. 2 Prior radiation therapy allowed to 25 of the bone marrow Cristy and Eckerman 1987 . Prior radiation to the whole pelvis is not allowed. Prior radiotherapy for palliative treatment must be completed at least 4 weeks before study enrollment. Patients must have recovered from the acute toxic effects of the treatment prior to study enrollment. 3 Life expectancy 8805;3 months. 4 Eastern Cooperative Oncology Group ECOG performance status 0, 1, or 2 Oken et al. 1982 . See Protocol Attachment JMHR.3. 5 Disease status may be measurable or nonmeasurable as defined by Response Evaluation Criteria in Solid Tumors RECIST; Therasse et al. 2000 . Positron emission tomography PET scans and ultrasounds may not be used for lesion measurements. 6 Patient compliance and geographic proximity that allow for adequate follow-up. 7 Adequate organ function as defined by the following Bone marrow reserve absolute neutrophil segmented and bands count ANC 8805;1.5 109/L, platelets 8805;100 109/L, and hemoglobin 8805;9 g/dL. Hepatic bilirubin 8804;1.5 the upper limit of normal ULN ; alkaline phosphatase ALP , aspartate aminotransferase AST , and alanine aminotransferase ALT 8804;3.0 ULN. ALP, AST, and ALT 8804;5.0 ULN is acceptable if the liver has tumor involvement. Renal calculated creatinine clearance CrCl 8805;60 mL/min based on the standard Cockcroft and Gault formula Cockcroft and Gault 1976 . See Protocol Attachment JMHR.4. 8 Signed informed consent from patient. 9 Patients at least 18 years of age. 10 For women Must be surgically sterile, postmenopausal, or compliant with a medically approved contraceptive regimen for example, intrauterine device IUD , birth control pills, or barrier device during and for 6 months after the treatment period; must have a negative serum or urine pregnancy test within 7 days before study enrollment, and must not be breast-feeding. For men Must be surgically sterile or compliant with a contraceptive regimen during and for 6 months after the treatment period.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
11 Prior systemic therapy chemotherapy or biological anticancer therapy for metastatic disease. 12 Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry. 13 Serious concomitant systemic disorder for example active infection or cardiac disease or psychiatric disorder that, in the opinion of the investigator, would compromise the patient s ability to complete the study. 14 Presence of clinically significant by physical exam third-space fluid collections, for example, ascites or pleural effusions that cannot be controlled by drainage or other procedures prior to study entry. 15 Second primary malignancy that is clinically detectable at the time of consideration for study enrollment. 16 Have had another primary malignancy other than HNC, unless that prior malignancy was treated at least 2 years previously with no evidence of recurrence. Exception Patients with a history of in situ carcinoma of the cervix, nonmelanoma skin cancer, or low-grade Gleason score 8804;6 localized prostate cancer will be eligible even if diagnosed and treated less than 2 years previously. 17 Nasopharyngeal, paranasal sinus, lip, or salivary gland cancer. 18 Have central nervous system CNS metastases unless the patient has completed successful local therapy for CNS metastases and has been off corticosteroids for at least 4 weeks before starting study therapy . Brain imaging is required in symptomatic patients to rule out brain metastases, but is not required in asymptomatic patients. 19 Inability to interrupt aspirin or other nonsteroidal anti-inflammatory agents, other than an aspirin dose 8804;1.3 grams per day, for a 5-day period 8-day period for long-acting agents, such as piroxicam . 20 Unable or unwilling to take folic acid, vitamin B12, or prophylactic corticosteroids. 21 Concurrent administration of any other antitumor therapy. 22 Pregnant or breast-feeding.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Patients affected by Head and Neck Cancer
MedDRA version: 6.1 Level: HLT Classification code 10024531

Intervention(s)

Trade Name: L01BA04 Pemetrexed pemetrexed disodico Alimta 1Fl Polv. 500mg
Product Name: pemetrexed
Pharmaceutical Form: Powder for infusion*
INN or Proposed INN: Pemetrexed
Current Sponsor code: H3E-MC-JMHR
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 500-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use

Trade Name: L01XA01 -cisplatino- Platinex INFUS Polv 50mg
Product Name: cisplatino
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Cisplatin
CAS Number: 15663-27-1
Current Sponsor code: H3E-MC-JMHR
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-

Trade Name: L01XA01 - Cisplatino Platinex INF Polv 50mg
Product Name: cisplatino
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Cisplatin
CAS Number: 15663-27-1
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-

Primary Outcome(s)

Main Objective: The primary objective of this study is to compare the OS of pemetrexed 500 mg/m2 plus cisplatin 75 mg/m2 every 3 weeks to the OS of single-agent cisplatin 75 mg/m2 every 3 weeks in patients with HNC that is recurrent and not amenable to local therapy surgery or radiation or newly diagnosed distant metastatic disease.

Primary end point(s): The primary objective of this study is to compare the OS of pemetrexed 500 mg/m2 plus cisplatin 75 mg/m2 every 3 weeks to the OS of single-agent cisplatin 75 mg/m2 every 3 weeks in patients with HNC that is recurrent and not amenable to local therapy surgery or radiation or newly diagnosed distant metastatic disease.

Secondary Objective: The secondary objectives of this study are to compare between the two treatment arms progression-free survival PFS overall response rate ORR duration of response DoR for responding patients time to worsening TTW in dimensions of health-related quality of life HRQoL using Functional Assessment of Cancer Therapy - Head and Neck Cancer FACT-H N change from baseline in dimensions of HRQoL using FACT-H N the safety and adverse event profile including Common Terminology Criteria for Adverse Events CTCAE Version 3.0, NCI 2003 grades for laboratory and nonlaboratory adverse events .

Secondary ID(s)

H3E-MC-JMHR

2006-003158-12-NL