Gemcitabine and Pemetrexed in Primary Unknown Adenocarcinoma

Adenocarcinoma Clinical Trial

Official title:

Phase II Study of Gemcitabine and Pemetrexed in Primary Unknown Adenocarcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00191503
• Other study ID #: 9508
• Secondary ID: H3E-CA-S070
• Status: Completed
• Phase: Phase 2
• First received: September 12, 2005
• Last updated: January 24, 2007
• Start date: January 2005
• Est. completion date: November 2005

Study information

• Verified date: January 2007
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Adenocarcinoma

Intervention

Drug:
• Pemetrexed

• Gemcitabine

Locations

Country	Name	City	State
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	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

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The secondary objectives include measures of disease control including overall survival and to describe the toxicities of therapy in this patient population.