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Gemcitabine and Pemetrexed in Primary Unknown Adenocarcinoma

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00191503
First received: September 12, 2005
Last updated: January 24, 2007
Last verified: January 2007
History of Changes
  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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Gemcitabine and Pemetrexed in Primary Unknown Adenocarcinoma

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

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
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
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

No publications provided

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

Additional relevant MeSH terms:
Adenocarcinoma
Adenocarcinoma, Mucinous
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Cystic, Mucinous, and Serous
Gemcitabine
Pemetrexed
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
 Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Folic Acid Antagonists

ClinicalTrials.gov processed this record on May 22, 2013