Trials / Completed
CompletedNCT00415194
A Study for Patients With Head and Neck Cancer
A Randomized Phase 3 Study of Pemetrexed in Combination With Cisplatin Versus Cisplatin Monotherapy in Patients With Recurrent or Metastatic Head and Neck Cancer
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 795 (actual)
- Sponsor
- Eli Lilly and Company · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study will compare the effects of pemetrexed plus cisplatin versus cisplatin alone in head and neck cancer patients.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | pemetrexed | 500 mg/m\^2, IV, every 21 days, six 21 day cycles |
| DRUG | cisplatin | 75 mg/m\^2, administered IV, every 21 days, six 21 day cycles |
| DRUG | placebo | Approximately 100 mL normal saline administered IV, every 21 days, six 21 day cycles |
Timeline
- Start date
- 2006-12-01
- Primary completion
- 2010-03-01
- Completion
- 2010-03-01
- First posted
- 2006-12-22
- Last updated
- 2011-06-28
- Results posted
- 2011-04-06
Locations
94 sites across 21 countries: United States, Argentina, Belgium, Brazil, China, Denmark, France, Germany, Hungary, India, Italy, Mexico, Netherlands, Poland, Puerto Rico, Romania, Russia, South Africa, South Korea, Spain, Taiwan
Source: ClinicalTrials.gov record NCT00415194. Inclusion in this directory is not an endorsement.