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

• Conditions: Recurrent or Metastatic Head and Neck Cancer; MedDRA version: 8.1Level: LLTClassification code 10060121Term: Squamous cell carcinoma of head and neck

• Registration Number: EUCTR2006-003158-12-DE
• Lead Sponsor: Eli Lilly and Company limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-09-20
• Last Update Posted: 10 February 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 790

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 of at least 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) =1.5 x 10e9/L, platelets =100 x 10e9/L, and hemoglobin =9 g/dL.
• Hepatic: bilirubin < or = 1.5 x the upper limit of normal (ULN); alkaline phosphatase (ALP), aspartate aminotransferase (AST), and alanine aminotransferase (ALT) >3.0 x ULN. (ALP, AST, and ALT >5.0 x ULN is acceptable if the liver has tumor involvement.)
• Renal: calculated creatinine clearance (CrCl) =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 =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 =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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified