Status:
COMPLETED
Gemcitabine and Pemetrexed in Primary Unknown Adenocarcinoma
Lead Sponsor:
Eli Lilly and Company
Conditions:
Adenocarcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
There is no standard treatment for the patient population being asked to participate in this study. Although one current regimen, used by some investigators, has a high rate of response compared to ot...
Eligibility Criteria
Inclusion
- Histologically proven adenocarcinoma
- No obvious primary on routine history, physical examination, and investigations
- Patients greater than or equal to 18 years of age
- ECOG Performance Status 0-1
- Patients requiring opioids for pain control must be on a fixed analgesic regimen aimed to provide adequate pain control with no more than 3 breakthrough (supplemental) doses of analgesics per day to control pain; Additional inclusion criteria due apply, but not are not listed here.
Exclusion
- 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
- Unable to stabilize pain and analgesics for a period of 7 days prior to starting study treatment
- Prior treatment with chemotherapy
- Bilirubin greater than or equal to 40 mol/L
- AST or ALT greater than or equal to 5 times the upper limit of normal (ULN); Additional exclusion criteria due apply, but not are not listed here.
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
End Date :
November 1 2005
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00191503
Start Date
January 1 2005
End Date
November 1 2005
Last Update
January 26 2007
Active Locations (2)
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1
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
Calgary, Alberta, Canada
2
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
Edmonton, Alberta, Canada