Study of Pemetrexed for Second-Line Pancreas Cancer
This study has been terminated.
(At interim analysis the study did not meet the response criteria to continue)
Sponsor:
Georgetown University
Collaborator:
Eli Lilly and Company
Information provided by:
Georgetown University
ClinicalTrials.gov Identifier:
NCT00864513
First received: March 17, 2009
Last updated: March 23, 2011
Last verified: March 2011
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Purpose
This study is for patients with pancreatic cancer that has grown and/or spread after having previously received the standard chemotherapy drug called gemcitabine.
In this study a drug called pemetrexed is being tested. This drug is approved by the FDA for use in lung cancer and mesothelioma. The purpose of this study is to see if pemetrexed keeps pancreas cancer that has grown and/or spread after gemcitabine from growing. Subjects will receive pemetrexed IV once every 21 days until disease progression or unacceptable side effects occur.
| Condition | Intervention | Phase |
|---|---|---|
|
Pancreas Cancer |
Drug: pemetrexed |
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: | A Phase II Study of Pemetrexed as Second-Line Treatment in Patients With Pancreatic Cancer Progressing Despite Therapy With Gemcitabine |
Resource links provided by NLM:
Further study details as provided by Georgetown University:
Primary Outcome Measures:
- Progression-free survival [ Time Frame: 6 months after last patient enrolled ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Objective response [ Time Frame: end of study treatment ] [ Designated as safety issue: No ]
- Time to progression [ Time Frame: 6 months after last patient enrolled ] [ Designated as safety issue: No ]
- CA 19-9 response [ Time Frame: end of study treatment ] [ Designated as safety issue: No ]
- Toxicities [ Time Frame: 30 days after last dose of study drug ] [ Designated as safety issue: Yes ]
| Enrollment: | 17 |
| Study Start Date: | October 2007 |
| Study Completion Date: | July 2009 |
| Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: chemotherapy
pemetrexed
|
Drug: pemetrexed
pemetrexed 500 mg/m2 IV day 1 of each 21 day cycle until disease progression or unacceptable toxicity for a maximum of 8 cycles
Other Names:
|
Detailed Description:
This is an open label Phase II trial using pemetrexed as second-line treatment in patients with advanced pancreatic cancer progressing within six months of prior gemcitabine-based therapy. Subjects will receive pemetrexed 500 mg/m2 IV every 21 days until disease progression or unacceptable toxicity.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Histologically confirmed adenocarcinoma of the pancreas
- Prior treatment for distant or locally advanced disease with gemcitabine-based therapy
- Measurable or evaluable disease
- ECOG performance status 0-2
- Adequate hematological parameters
- Adequate baseline liver function
- At least 28 days from any major surgery
- At least 2 weeks from the last radiation treatment
- Must have recovered from reversible toxicities of prior chemotherapy
- Must be able to discontinue any nonsteroidal anti-inflammatory medications
- Must be willing to receive intramuscular vitamin B12 shots and take oral folate supplements
Exclusion Criteria:
- Any prior treatment with pemetrexed
- More than one prior chemotherapy regimen
- HIV positive on antiretroviral therapy
- Pregnant or lactating
- Prior organ allograft
- On concurrent antitumor therapy including radiation therapy or other chemotherapies
- Creatinine clearance 45 ml/min or less
- Absolute neutrophil count < 1500
- Platelets < 75,000
- Bilirubin > 1.5 times the upper limit of normal
- Transaminases > 3 times the upper limit of normal except in known liver metastasis wherein they may be </= 5 times upper limit of normal
- Clinically significant ascites or pleural effusion that cannot be drained
- Any medical or psychiatric condition that may interfere with the ability to comply with protocol treatment
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00864513
Locations
| United States, District of Columbia | |
| Georgetown University Hospital/Lombardi Cancer Center | |
| Washington, District of Columbia, United States, 20007 | |
Sponsors and Collaborators
Georgetown University
Eli Lilly and Company
Investigators
| Principal Investigator: | Jimmy J Hwang, M.D. | Georgetown University |
More Information
No publications provided
| Responsible Party: | Jimmy Hwang, MD, Georgetown University |
| ClinicalTrials.gov Identifier: | NCT00864513 History of Changes |
| Other Study ID Numbers: | IIT2007022, 2007-022 |
| Study First Received: | March 17, 2009 |
| Last Updated: | March 23, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Georgetown University:
|
pancreas metastatic recurrent |
Additional relevant MeSH terms:
|
Pancreatic Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases Pemetrexed |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Folic Acid Antagonists Antimetabolites, Antineoplastic Antimetabolites |
ClinicalTrials.gov processed this record on May 23, 2013