Gemcitabine and Pemetrexed in Primary Unknown Adenocarcinoma
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00191503 |
Recruitment Status :
Completed
First Posted : September 19, 2005
Last Update Posted : January 26, 2007
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Adenocarcinoma | Drug: Pemetrexed Drug: Gemcitabine | Phase 2 |
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 |

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

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | 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:
- 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.

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
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 |
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 |
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 |
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 |