A Study for Patients With Recurrent or Metastatic Squamous Cell Head and Neck Cancer

NCT ID: NCT01057589

Last Updated: 2013-09-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-02-28
• Study Completion Date: 2012-10-31

Brief Summary

The purpose of this trial is to estimate progression free survival in patients with recurrent or metastatic head and neck cancer that have not received chemotherapy in this setting.

Detailed Description

A 12 patient safety lead will evaluate side effects in patients receiving at least 2 cycles of the combination pemetrexed, cisplatin and cetuximab.

Conditions

Head and Neck Neoplasms

Keywords

Pharynx; Larynx; Cervical esophagus; Nose; Thyroid Gland; Parathyroid Gland

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pemetrexed + Cisplatin + Cetuximab

Participants will receive pemetrexed,cisplatin and cetuximab for up to 6 cycles (21 days per cycle) followed by optional maintenance of pemetrexed and cetuximab until disease progression. Optional maintenance therapy is permitted after at least 4 cycles of triplet combination therapy have been given. Cetuximab will be administered as an initial dose of 400 milligram per meter squared (mg/m^2) intravenous (IV) infusion and as a 250 mg/m^2 IV weekly dose thereafter.

As Standard of care dietary supplements included: 350 to 1000 micrograms (µg) oral Folic Acid 5 times a day for the 7 days preceding the first dose of first dose of pemetrexed and continuing throughout treatment and for 21 days after the last dose of pemetrexed and 1000 µg vitamin B12 intramuscular injection (IM) during the week preceding the first dose of pemetrexed and every 9 weeks thereafter.

Group Type: EXPERIMENTAL

Pemetrexed

Intervention Type: DRUG

Triplet Combination Therapy: 500 mg/m^2 administered intravenously on Day 1 of 21 day cycle for up to 6 cycles

Maintenance Therapy: 500mg/m^2 administered intravenously on Day 1 of 21 day cycle until disease progression or unacceptable toxicity

Cetuximab

Intervention Type: DRUG

Triplet Combination Therapy: 400 mg/m^2 administered intravenously on Day 1 of 21 day cycle for 1 cycle; 250 mg/m^2 administered IV infusion on Day 1 of 21 day cycle and then weekly for up to 6 cycles.

Maintenance Therapy: 250 mg/m^2 administered intravenously on Day 1 of 21 day cycle and then weekly until disease progression or unacceptable toxicity

Cisplatin

Intervention Type: DRUG

Triplet Combination Therapy: 75mg/m\^2 administered intravenously on Day 1 of 21 day cycle for up to 6 cycles.

Folic Acid

Intervention Type: DIETARY_SUPPLEMENT

Standard of care dietary supplements: 350 to 1000 µg orally 5 times a day for the 7 days preceding the first dose of first dose of pemetrexed and continuing throughout treatment and for 21 days after the last dose of pemetrexed.

Vitamin B12

Intervention Type: DIETARY_SUPPLEMENT

Standard of care dietary supplements: 1000 µg IM during the week preceding the first dose of pemetrexed and every 9 weeks thereafter.

Interventions

Pemetrexed

Triplet Combination Therapy: 500 mg/m^2 administered intravenously on Day 1 of 21 day cycle for up to 6 cycles

Maintenance Therapy: 500mg/m^2 administered intravenously on Day 1 of 21 day cycle until disease progression or unacceptable toxicity

Intervention Type: DRUG

Cetuximab

Triplet Combination Therapy: 400 mg/m^2 administered intravenously on Day 1 of 21 day cycle for 1 cycle; 250 mg/m^2 administered IV infusion on Day 1 of 21 day cycle and then weekly for up to 6 cycles.

Maintenance Therapy: 250 mg/m^2 administered intravenously on Day 1 of 21 day cycle and then weekly until disease progression or unacceptable toxicity

Intervention Type: DRUG

Cisplatin

Triplet Combination Therapy: 75mg/m\^2 administered intravenously on Day 1 of 21 day cycle for up to 6 cycles.

Intervention Type: DRUG

Folic Acid

Standard of care dietary supplements: 350 to 1000 µg orally 5 times a day for the 7 days preceding the first dose of first dose of pemetrexed and continuing throughout treatment and for 21 days after the last dose of pemetrexed.

Intervention Type: DIETARY_SUPPLEMENT

Vitamin B12

Standard of care dietary supplements: 1000 µg IM during the week preceding the first dose of pemetrexed and every 9 weeks thereafter.

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Alimta; LY231514

Eligibility Criteria

Inclusion Criteria

• Histologically confirmed diagnosis of squamous cell carcinoma of head and neck (SCCHN)
• Recurrent or metastatic SCCHN, not amenable to local therapy
• At least 6 months since completion of systemic therapy (chemotherapy or biological anticancer therapy)
• No more than 1 prior systemic therapy, given as part of multimodal treatment for locally advanced disease;
• No prior systemic therapy for metastatic disease
• Radiation therapy must be completed at least 4 weeks before study enrollment.
• For palliative therapy, prior radiation therapy allowed to <25% of the bone marrow (Cristy and Eckerman 1987), and prior radiation to the whole pelvis is not allowed.
• Surgery (excluding prior diagnostic biopsy) must be completed at least 4 weeks before study enrollment.
• An estimated life expectancy of at least 12 weeks.
• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 (Oken et al. 1982).
• Biological tissue available for biomarker analysis on tumor tissue.
• Disease status may be measurable or nonmeasurable as defined by Response Evaluation Criteria in Solid Tumors
• Patient compliance and geographic proximity that allow for adequate follow-up.
• Adequate organ function
• Willingness to comply with Contraceptive Regimen
• 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.

Exclusion Criteria

• Nasopharyngeal, paranasal sinus, lip, or salivary gland cancer.
• Previously received treatment with monoclonal antibody therapy, or other signal transduction inhibitors of Epidermal Growth Factor Receptor therapy.
• Are receiving concurrent chronic systemic immune therapy, or chemotherapy for a disease other than cancer.
• Serious concomitant systemic disorder (for example, active infection) or psychiatric disorder that, in the opinion of the investigator, would compromise the patient's ability to complete the study.
• Have serious cardiac disease, such as symptomatic , unstable angina, or the history of myocardial infarction in the previous 12 months.
• Second primary malignancy that is clinically detectable at the time of consideration for study enrollment.
• Have had another primary malignancy other than Head and Neck cancer, 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 less than or equal to 6) localized prostate cancer will be eligible even if diagnosed and treated less than 2 years previously.
• 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.
• Have peripheral neuropathy
• 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.
• Inability to interrupt aspirin or other nonsteroidal anti-inflammatory agents, other than an aspirin dose less than or equal to 1.3 grams per day, for a 5-day period (8-day period for long-acting agents, such as piroxicam).
• Unable or unwilling to take folic acid, vitamin B12, or prophylactic corticosteroids.
• Recent (within 30 days before enrollment) or concurrent yellow fever vaccination.
• Pregnant or breast-feeding

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5PM Eastern time (UTC/GMT - 5 hours, EST

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Edegem, , Belgium

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Saint-Herblain, , France

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Dresden, , Germany

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Essen, , Germany

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Hanover, , Germany

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Leipzig, , Germany

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Milan, , Italy

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Barcelona, , Spain

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Madrid, , Spain

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Pamplona, , Spain

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Valencia, , Spain

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

London, London, United Kingdom

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Cardiff, South Glamorgan, United Kingdom

Countries

Belgium; France; Germany; Italy; Spain; United Kingdom

References

Cristy M, Eckerman KF. 1987. Specific absorbed fractions of energy at various ages from internal sources: I. methods. Prepared by the Oak Ridge National Laboratory, Oak Ridge, Tenn.

Reference Type: BACKGROUND

Oken MM, Creech RH, Tormey DC, Horton J, Davis TE, McFadden ET, Carbone PP. Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol. 1982 Dec;5(6):649-55. No abstract available.

Reference Type: BACKGROUND

PMID: 7165009 (View on PubMed)

Vermorken JB, Licitra L, Stohlmacher-Williams J, Dietz A, Lopez-Picazo JM, Hamid O, Hossain AM, Chang SC, Gauler TC. Phase II study of pemetrexed in combination with cisplatin and cetuximab in recurrent or metastatic squamous cell carcinoma of the head and neck. Eur J Cancer. 2013 Sep;49(13):2877-83. doi: 10.1016/j.ejca.2013.05.002. Epub 2013 May 30.

Reference Type: DERIVED

PMID: 23726971 (View on PubMed)

Other Identifiers

H3E-MC-S123

Identifier Type: OTHER

Identifier Source: secondary_id

12170

Identifier Type: -

Identifier Source: org_study_id