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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-022 |
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At interim analysis the study did not meet the response criteria to continue
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| Name | Class |
|---|---|
| Eli Lilly and Company | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| chemotherapy | Experimental | pemetrexed |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pemetrexed | Drug | pemetrexed 500 mg/m2 IV day 1 of each 21 day cycle until disease progression or unacceptable toxicity for a maximum of 8 cycles |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival | Number of days from first dose of study treatment until the date of progression, as measured by worsening disease (new site of disease, or increase in existing disease) or death. | 6 months after last patient enrolled |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response | Evaluation of tumor extent by CT scans, according to RECIST criteria (a 20% decrease in the sum of the longest unidimensional measurements of existing disease), version 1.0 | Within two months of the completion of the last dose of chemotherapy |
| CA 19-9 Response |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jimmy J Hwang, M.D. | Georgetown University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Georgetown University Hospital/Lombardi Cancer Center | Washington D.C. | District of Columbia | 20007 | United States |
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From 12/2007 to 3/2009 17 patients were enrolled; 2 of which did not receive any treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Chemotherapy | Subjects will be treated with pemetrexed 500 mg/m2 IV once every 21 days. They are also premdicated with dexamethasone 4 mg po BID on the day before, of and after chemotherapy. They will start folic acid 350-1000mcg by mouth daily, 5-7 days before starting study therapy. They will also receive a 1000 mcg IM injeciton of vitamin B12 1-2 weeks before study drug, and eveyr 9 weeks thereafter, until 3 weeks after the last dose of study treatment |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Chemotherapy | pemetrexed |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Progression-free Survival | Number of days from first dose of study treatment until the date of progression, as measured by worsening disease (new site of disease, or increase in existing disease) or death. | Posted | Median | Full Range | days | 6 months after last patient enrolled |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Chemotherapy | pemetrexed |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
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study was closed at interim analysis so only 12 subjects were evaluable for response, 15 subjects received treatment and were evaluable for adverse events
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jimmy Hwang | Georgetown University | 202-444-2198 | jh96@gunet.georgetown.edu |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| D009362 | Neoplasm Metastasis |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| ID | Term |
|---|---|
| D000068437 | Pemetrexed |
| ID | Term |
|---|---|
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 |
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CA 19-9 was evaluatd every three weeks, before the next study treatment. Approximately 30% of patients are not expected to have detectable CA 19-9, based on Lews-Y antigen. CA 19-9 response is defined as more than 50% decrease from baseline. |
| Within two months of the last dose of chemotherapy |
| Number of Participants With Adverse Events | Toxicity by National Cancer Institute Common Toxicity Criteria Adverse Event Version 3.0 | 30 days after last dose of study drug |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | Objective Response | Evaluation of tumor extent by CT scans, according to RECIST criteria (a 20% decrease in the sum of the longest unidimensional measurements of existing disease), version 1.0 | Posted | Number | participants | Within two months of the completion of the last dose of chemotherapy |
|
|
|
| Secondary | CA 19-9 Response | CA 19-9 was evaluatd every three weeks, before the next study treatment. Approximately 30% of patients are not expected to have detectable CA 19-9, based on Lews-Y antigen. CA 19-9 response is defined as more than 50% decrease from baseline. | Only 10 patients had elevated CA 19-9 at the start of therapy, and were therefore analyzable for this endpoint | Posted | Number | participants | Within two months of the last dose of chemotherapy |
|
|
|
| Secondary | Number of Participants With Adverse Events | Toxicity by National Cancer Institute Common Toxicity Criteria Adverse Event Version 3.0 | Posted | Number | participants | 30 days after last dose of study drug |
|
|
|
| 2 |
| 15 |
| 0 |
| 15 |
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| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020969 | Disease Attributes |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000600 | Amino Acids, Dicarboxylic |