Gemcitabine and Pemetrexed in Primary Unknown Adenocarcinoma - Full Text View

Sponsored by:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00191503

Purpose

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	Intervention	Phase
Adenocarcinoma	Drug: Pemetrexed Drug: Gemcitabine	Phase II

MedlinePlus related topics: Cancer

Drug Information available for: Gemcitabine hydrochloride Gemcitabine Pemetrexed disodium Pemetrexed

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	Phase II Study of Gemcitabine and Pemetrexed in Primary Unknown Adenocarcinoma

Further study details as provided by Eli Lilly and Company:

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.

Estimated Enrollment:	30
Study Start Date:	January 2005
Estimated Study Completion Date:	November 2005

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00191503

Locations

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
Edmonton, 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
Calgary, Alberta, Canada

Sponsors and Collaborators

Eli Lilly and Company

Investigators

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

Study ID Numbers:	9508, H3E-CA-S070
Study First Received:	September 12, 2005
Last Updated:	January 24, 2007
ClinicalTrials.gov Identifier:	NCT00191503
Health Authority:	Canada: Health Canada

Study placed in the following topic categories:

Folic Acid
Pemetrexed
Gemcitabine

Adenocarcinoma
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs

Enzyme Inhibitors
Folic Acid Antagonists
Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on January 16, 2009