Gemcitabine and Pemetrexed in Primary Unknown Adenocarcinoma

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ClinicalTrials.gov Identifier: NCT00191503

Recruitment Status : Completed

First Posted : September 19, 2005

Last Update Posted : January 26, 2007

Sponsor:

Information provided by:

Eli Lilly and Company

Study Description

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 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.

Condition or disease	Intervention/treatment	Phase
Adenocarcinoma	Drug: Pemetrexed Drug: Gemcitabine	Phase 2

Study Design

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Study Type :	Interventional (Clinical Trial)
Enrollment :	30 participants
Allocation:	Non-Randomized
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Phase II Study of Gemcitabine and Pemetrexed in Primary Unknown Adenocarcinoma
Study Start Date :	January 2005
Study Completion Date :	November 2005

Resource links provided by the National Library of Medicine

Drug Information available for: Gemcitabine Gemcitabine hydrochloride Pemetrexed Pemetrexed disodium

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00191503

Locations

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Canada, Alberta
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

Sponsors and Collaborators

Eli Lilly and Company

Investigators

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Study Director:	Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9am - 5pm Eastern Time (UTC/GMT - 5 hours, EST)	Eli Lilly and Company

More Information

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ClinicalTrials.gov Identifier:	NCT00191503
Other Study ID Numbers:	9508 H3E-CA-S070
First Posted:	September 19, 2005 Key Record Dates
Last Update Posted:	January 26, 2007
Last Verified:	January 2007

Additional relevant MeSH terms:

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Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Gemcitabine Pemetrexed Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action	Antineoplastic Agents Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors

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