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CompletedNCT00191503Updated Jan 26, 2007

Gemcitabine and Pemetrexed in Primary Unknown Adenocarcinoma

A Phase 2 interventional study of Pemetrexed and Gemcitabine in Adenocarcinoma, sponsored by Eli Lilly and Company. Completed at 2 sites in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2007-01-26.

Sponsored by Eli Lilly and Company · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
30
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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 other therapies, it is associated with moderate to severe toxicity. As gemcitabine and pemetrexed have a broad range of activity against cancer it is reasonable to determine how active and safe they are against patients with this type of cancer.The objective of this study is to determine the anti-tumor activity of pemetrexed and gemcitabine in patients with this condition.

02

Conditions studied

  • Adenocarcinoma

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03

In context

Adenocarcinoma

2,004 studies on the registry are indexed under Adenocarcinoma; 375 are open to participants now.

This study's enrollment of 30 is below the median of 45 across 1,553 interventional studies indexed under Adenocarcinoma.

Browse Adenocarcinoma studies →

Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.

Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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 criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants

Interventions

  • DrugPemetrexed
  • DrugGemcitabine
06

What researchers measure

Primary outcomes

  1. The primary purpose of this study is to determine the objective response rate (ORR) for pemetrexed and gemcitabine when administered every two weeks to patients with adenocarcinoma of unknown origin who present with predominant liver metastases.

Secondary outcomes

  1. The secondary objectives include measures of disease control including overall survival and to describe the toxicities of therapy in this patient population.

07

Study locations

2 sites
  • 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
  • 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
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 26, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00191503
Lead sponsor
Eli Lilly and Company
First posted
Sep 19, 2005
Start date
Jan 2005
Completion
Nov 2005
Last update
Jan 26, 2007

Study contacts

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9am - 5pm Eastern Time (UTC/GMT - 5 hours, EST)
study director · Eli Lilly and Company
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2007. You cannot join it, but the record below documents what was studied.

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