Trial · NCT00369629
Gemcitabine and Pemetrexed Disodium in Treating Patients With Advanced Mycosis Fungoides or Sézary Syndrome
NCT00369629, Phase 1, Terminated, Northwestern University; results first posted 2018-10-09
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Gemcitabine and Pemetrexed Disodium in Treating Patients With Advanced Mycosis Fungoides or Sézary Syndrome. Trials, record NCT00369629. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00369629
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Gemcitabine and Pemetrexed Disodium in Treating Patients With Advanced Mycosis Fungoides or Sézary Syndrome
- NCT number
- NCT00369629
- Status
- Terminated
- Phases
- Phase 1
- Enrollment
- 14 participants, actual
- Lead sponsor
- Northwestern University
- Conditions
- Lymphoma
- Interventions
- Gemcitabine, Pemetrexed
- First posted
- 2006-08-29
- Last updated
- 2019-08-28
- Results first posted
- 2018-10-09
- Limitations and caveats
- The study was terminated early before the last patient was enrolled in phase I due to lack of funding. The phase II portion was never conducted.
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum Tolerated Dose as Measured by the Number of Dose Limiting Toxicities Seen in Cohort. | From the day that the first treatment is given through the first 28 day period for each patient. | Only dose limiting toxicities (DLT) were collected. DLTs were graded according to the National Cancer Institute's Common Toxicity Criteria for adverse events version 3.0 (CTCAE v3.0) according to the following: Grade 1 Mild AE Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or disabling AE Grade 5 Death related to AE The occurrence of any of the following toxicities during the first treatment cycle constitutes DLT in this study: Grade 3 and/or 4 non-hematologic toxicity other than grade 3 nausea or vomiting. Grade 3 and/or 4 unexpected non-hematologic toxicities. Grade 4 vomiting despite maximal antiemetic support. Grade 4 neutropenia and fever during first cycle. Grade 4 neutropenia on Day 1 of 2nd treatment cycle despite growth factor support or grade 4 thrombocytopenia on Day 1 of 2nd treatment cycle. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Maximum Tolerated Dose as Measured by the Number of Dose Limiting Toxicities Seen in Cohort. | From the day that the first treatment is given through the first 28 day period for each patient. | Patients that experienced a DLT in the first cycle in each cohort. If one DLT is seen in the first 3 patients then 3 more patients are enrolled in that cohort. MTD and is defined as the lowest dose level at which two or more patients experience a DLT. The study closed before enough patients were enrolled to determine the MTD or define DLTs. | DLT | NUMBER |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Maximum Tolerated Dose as Measured by the Number of Dose Limiting Toxicities Seen in Cohort. | Cohort 1 | Perforated sigmoid diverticulitis | 1 | DLT | |
| Maximum Tolerated Dose as Measured by the Number of Dose Limiting Toxicities Seen in Cohort. | Cohort 2 | Perforated sigmoid diverticulitis | 0 | DLT | |
| Maximum Tolerated Dose as Measured by the Number of Dose Limiting Toxicities Seen in Cohort. | Cohort 3 | Perforated sigmoid diverticulitis | 0 | DLT | |
| Maximum Tolerated Dose as Measured by the Number of Dose Limiting Toxicities Seen in Cohort. | Cohort 1 | Febrile neutropenia | 0 | DLT | |
| Maximum Tolerated Dose as Measured by the Number of Dose Limiting Toxicities Seen in Cohort. | Cohort 2 | Febrile neutropenia | 0 | DLT | |
| Maximum Tolerated Dose as Measured by the Number of Dose Limiting Toxicities Seen in Cohort. | Cohort 3 | Febrile neutropenia | 1 | DLT |
Source ClinicalTrials.gov
Participant flow48
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Treated 2 Cycles/Reached First Response | STARTED | Cohort 1 | 6 | |
| Treated 2 Cycles/Reached First Response | STARTED | Cohort 2 | 3 | |
| Treated 2 Cycles/Reached First Response | STARTED | Cohort 3 | 5 | |
| Treated 2 Cycles/Reached First Response | STARTED | Cohort 4 | 0 | |
| Treated 2 Cycles/Reached First Response | COMPLETED | Cohort 1 | 4 | |
| Treated 2 Cycles/Reached First Response | COMPLETED | Cohort 2 | 2 | |
| Treated 2 Cycles/Reached First Response | COMPLETED | Cohort 3 | 3 | |
| Treated 2 Cycles/Reached First Response | COMPLETED | Cohort 4 | 0 | |
| Treated 2 Cycles/Reached First Response | NOT COMPLETED | Cohort 1 | 2 | |
| Treated 2 Cycles/Reached First Response | NOT COMPLETED | Cohort 2 | 1 |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 participant flowAdverse events292
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | allergic rhinitis | Immune system disorders | Cohort 1 | 0 | 6 | |
| other | allergic rhinitis | Immune system disorders | Cohort 2 | 1 | 3 | |
| other | allergic rhinitis | Immune system disorders | Cohort 3 | 0 | 5 | |
| other | allergic rhinitis | Immune system disorders | Cohort 4 | 0 | 0 | |
| other | Otitis, external ear | Ear and labyrinth disorders | Cohort 1 | 1 | 6 | |
| other | Otitis, external ear | Ear and labyrinth disorders | Cohort 2 | 0 | 3 | |
| other | Otitis, external ear | Ear and labyrinth disorders | Cohort 3 | 0 | 5 | |
| other | Otitis, external ear | Ear and labyrinth disorders | Cohort 4 | 0 | 0 | |
| other | Hemoglobin | Blood and lymphatic system disorders | Cohort 1 | 6 | 6 | |
| other | Hemoglobin | Blood and lymphatic system disorders | Cohort 2 | 2 | 3 |
1 to 10 of 292Source ClinicalTrials.gov
See all 292 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort 1 | 5 | 6 |
| Total, all-cause mortality | Cohort 2 | 2 | 3 |
| Total, all-cause mortality | Cohort 3 | 2 | 5 |
| Total, all-cause mortality | Cohort 4 | 0 | 0 |
| Total, other adverse events | Cohort 1 | 6 | 6 |
| Total, other adverse events | Cohort 2 | 3 | 3 |
| Total, other adverse events | Cohort 3 | 5 | 5 |
| Total, other adverse events | Cohort 4 | 0 | 0 |
| Total, serious adverse events | Cohort 1 | 2 | 5 |
| Total, serious adverse events | Cohort 2 | 0 | 3 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P30CA060553 | The Robert H. Lurie Comprehensive Cancer Center | PLATANIAS, LEONIDAS C. | NORTHWESTERN UNIVERSITY | NATIONAL CANCER INSTITUTE | 1993 to 2025 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00369629
GET https://conductscience.org/api/trials/v1/NCT00369629/flow?page=2