A Phase 1 interventional study of Gemcitabine and Pemetrexed in Lymphoma, sponsored by Northwestern University. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-08-28.
Sponsored by Northwestern University · Phase 1, Interventional, and Treatment
RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Pemetrexed disodium may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving gemcitabine together with pemetrexed disodium may kill more cancer cells.
PURPOSE: This was planned as a phase I/II trial studying the side effects and determining the best dose of gemcitabine hydrochloride when given together with pemetrexed disodium. Unfortunately, due to a lack of funding, the phase II portion was never conducted.
OBJECTIVES:
OUTLINE: This is a phase I, dose-escalation study of gemcitabine hydrochloride. Originally, this was designed to be followed by a phase II portion to determine the efficacy in this population. Unfortunately, due to a lack of funding, the phase II portion was never conducted.
During Phase I: Patients receive pemetrexed disodium IV over 10 minutes and gemcitabine hydrochloride IV on days 1 and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of gemcitabine hydrochloride until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which ≥ 2 of 6 patients experience dose-limiting toxicity.
539 studies on the registry are indexed under Mycoses; 55 are open to participants now.
This study's enrollment of 14 is below the median of 46 across 358 interventional studies indexed under Mycoses.
Browse Mycoses studies →Northwestern University is the lead sponsor of 1,396 studies on the registry; 199 are open to participants now.
Of its 102 completed or terminated interventional studies of FDA-regulated products, 73 (72%) have results posted.
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DISEASE CHARACTERISTICS:
Histologically confirmed* mycosis fungoides or Sézary syndrome
Measurable disease
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Pemetrexed at a dose of 400 mg/m2 will be given to patients on day 1 and day 15 of 28 day cycle. Gemcitabine at a dose of 800 mg/m2 will be given following pemetrexed on day 1 and 15 of a 28-day cycle.
Drug: Gemcitabine · Drug: Pemetrexed
Pemetrexed at a dose of 500 mg/m2 will be given to patients on day 1 and day 15 of 28 day cycle. Gemcitabine at a dose of 800 mg/m2 will be given following pemetrexed on day 1 and 15 of a 28-day cycle.
Drug: Gemcitabine · Drug: Pemetrexed
Pemetrexed at a dose of 500 mg/m2 will be given to patients on day 1 and day 15 of 28 day cycle. Gemcitabine at a dose of 1000 mg/m2 will be given following pemetrexed on day 1 and 15 of a 28-day cycle.
Drug: Gemcitabine · Drug: Pemetrexed
Pemetrexed at a dose of 500 mg/m2 will be given to patients on day 1 and day 15 of 28 day cycle. Gemcitabine at a dose of 1200 mg/m2 will be given following pemetrexed on day 1 and 15 of a 28-day cycle.
Drug: Gemcitabine · Drug: Pemetrexed
Patients will be treated in cohorts of 3-6 per cohort. The starting dose of gemcitabine will be 800 mg/m\^2 given as an intravenous (IV) infusion on days 1 and 15 of each 28-day cycle. The dose will be escalated for each subsequent cohort of patients, up to a maximum of 1200 mg/m\^2.
Patients will be treated in cohorts of 3-6 per cohort. The starting dose of pemetrexed will be 400 mg/m\^2 given as an intravenous (IV) infusion on days 1 and 15 of each 28-day cycle. The dose will be escalated for each subsequent cohort of patients, up to a maximum of 500 mg/m\^2.
Maximum Tolerated Dose as Measured by the Number of Dose Limiting Toxicities Seen in Cohort.
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.
Time frame: From the day that the first treatment is given through the first 28 day period for each patient.
The study opened for accrual on June 6, 2006 in phase I with a 3+3 cohort design to find the recommended phase II dose. Phase II would expand to enroll a total of 20 evaluable patients at the recommended dose. The study was closed permanently on September 12, 2012 after 14 patients had been enrolled in the phase I part.
| Milestone | Cohort 1 | Cohort 2 | Cohort 3 | Cohort 4 |
|---|---|---|---|---|
| Started | 6 | 3 | 5 | 0 |
| Completed | 4 | 2 | 3 | 0 |
| Not completed | 2 | 1 | 2 | 0 |
| Withdrew: Physician decision | 0 | 1 | 1 | 0 |
| Withdrew: Adverse event | 0 | 0 | 1 | 0 |
| Withdrew: Progressive disease | 2 | 0 | 0 | 0 |
| Milestone | Cohort 1 | Cohort 2 | Cohort 3 | Cohort 4 |
|---|---|---|---|---|
| Started | 4 | 2 | 3 | 0 |
| Completed | 4 | 2 | 2 | 0 |
| Not completed | 0 | 0 | 1 | 0 |
| Withdrew: Progressive disease | 0 | 0 | 1 | 0 |
| Milestone | Cohort 1 | Cohort 2 | Cohort 3 | Cohort 4 |
|---|---|---|---|---|
| Started | 4 | 2 | 2 | 0 |
| Completed | 0 | 0 | 0 | 0 |
| Not completed | 4 | 2 | 2 | 0 |
| Withdrew: Withdrawal by subject | 2 | 1 | 0 | 0 |
| Withdrew: Progressive disease | 2 | 1 | 2 | 0 |
| Milestone | Cohort 1 | Cohort 2 | Cohort 3 | Cohort 4 |
|---|---|---|---|---|
| Started | 6 | 3 | 5 | 0 |
| Completed | 4 | 1 | 2 | 0 |
| Not completed | 2 | 2 | 3 | 0 |
| Withdrew: Death | 2 | 1 | 1 | 0 |
| Withdrew: Lost to follow-up | 0 | 1 | 0 | 0 |
| Withdrew: Stopped being followed as study closed | 0 | 0 | 2 | 0 |
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.
| DLT | Cohort 1 | Cohort 2 | Cohort 3 | Cohort 4 |
|---|---|---|---|---|
| Perforated sigmoid diverticulitis | 1 | 0 | 0 | — |
| Febrile neutropenia | 0 | 0 | 1 | — |
Collected over Adverse events were collected over a 6 year period for the study. Adverse events were collected from the start of treatment every 14 days until 30 days after the last treatment, for a maximum of 6 cycles. 1 cycle =28 days.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cohort 1 | 5/6 (83.3%) | 2/5 (40%) | 6/6 (100%) |
| Cohort 2 | 2/3 (66.7%) | 0/3 (0%) | 3/3 (100%) |
| Cohort 3 | 2/5 (40%) | 1/5 (20%) | 5/5 (100%) |
| Cohort 4 | — | — | — |
| Event | Cohort 1 | Cohort 2 | Cohort 3 | Cohort 4 |
|---|---|---|---|---|
| Perforated sigmoid diverticulitisGastrointestinal disorders | 1/5 | 0/3 | 0/5 | — |
| Bacteremia CMVInfections and infestations | 1/5 | 0/3 | 0/5 | — |
| Febrile neutropeniaInfections and infestations | 0/5 | 0/3 | 1/5 | — |
| PneumoniaInfections and infestations | 1/5 | 0/3 | 0/5 | — |
| Line sepsis and neutropeniaInfections and infestations | 1/5 | 0/3 | 0/5 | — |
| Event | Cohort 1 | Cohort 2 | Cohort 3 | Cohort 4 |
|---|---|---|---|---|
| HemoglobinBlood and lymphatic system disorders | 6/6 | 2/3 | 4/5 | — |
| FatigueGeneral disorders | 2/6 | 3/3 | 4/5 | — |
| Albumin, serum-lowMetabolism and nutrition disorders | 4/6 | 1/3 | 5/5 | — |
| Glucose, serum-high (hyperglycemia)Metabolism and nutrition disorders | 4/6 | 3/3 | 4/5 | — |
| LymphopeniaBlood and lymphatic system disorders | 5/6 | 1/3 | 4/5 | — |
| CreatinineMetabolism and nutrition disorders | 5/6 | 1/3 | 2/5 | — |
| ConstipationGastrointestinal disorders | 0/6 | 1/3 | 4/5 | — |
| Edema, LimbBlood and lymphatic system disorders | 1/6 | 0/3 | 4/5 | — |
| Platelets (thrombocytopenia)Blood and lymphatic system disorders | 4/6 | 1/3 | 2/5 | — |
| Pruritus/itchingSkin and subcutaneous tissue disorders | 4/6 | 1/3 | 1/5 | — |
| Age, Categorical(Participants) | Gemcitabine and Pemetrexed Disodium |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 10 |
| >=65 years | 4 |
| Sex: Female, Male(Participants) | Gemcitabine and Pemetrexed Disodium |
|---|---|
| Female | 5 |
| Male | 9 |
| Ethnicity (NIH/OMB)(Participants) | Gemcitabine and Pemetrexed Disodium |
|---|---|
| Hispanic or Latino | 1 |
| Not Hispanic or Latino | 13 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Gemcitabine and Pemetrexed Disodium |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 3 |
| White | 11 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(Participants) | Gemcitabine and Pemetrexed Disodium |
|---|---|
| United States | 14 |
This study is terminated, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
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