Know Cancer

or
forgot password

Phase II Study of Gemcitabine and Pemetrexed in Primary Unknown Adenocarcinoma


Phase 2
18 Years
N/A
Not Enrolling
Both
Adenocarcinoma

Thank you

Trial Information

Phase II Study of Gemcitabine and Pemetrexed in Primary Unknown Adenocarcinoma


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:

- 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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Principal Investigator

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9am - 5pm Eastern Time (UTC/GMT - 5 hours, EST)

Investigator Role:

Study Director

Investigator Affiliation:

Eli Lilly and Company

Authority:

Canada: Health Canada

Study ID:

9508

NCT ID:

NCT00191503

Start Date:

January 2005

Completion Date:

November 2005

Related Keywords:

  • Adenocarcinoma
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous

Name

Location