A Phase 2 interventional study of cisplatin and etoposide in Lymphoma, sponsored by SWOG Cancer Research Network. Completed at 77 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-10-01.
Sponsored by SWOG Cancer Research Network · Phase 2, Interventional, and Treatment
RATIONALE: Drugs used in chemotherapy, such as cisplatin, etoposide, gemcitabine, and methylprednisolone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.
PURPOSE: This phase II trial is studying how well combination chemotherapy works in treating patients with newly diagnosed stage II, stage III, or stage IV T-cell non-Hodgkin's lymphoma.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a pilot, multicenter study.
Patients receive cisplatin IV over 30-60 minutes, etoposide IV over 30-60 minutes, and methylprednisolone IV over 5 minutes on days 1-4. Patients also receive gemcitabine IV over 30-60 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed at 3-6 weeks, 3 months, and then every 6 months for up to 3 years.
PROJECTED ACCRUAL: A total of 55 patients will be accrued for this study within 3 years.
5,623 studies on the registry are indexed under Lymphoma; 823 are open to participants now.
This study's enrollment of 34 is below the median of 40 across 4,534 interventional studies indexed under Lymphoma.
Browse Lymphoma studies →SWOG Cancer Research Network is the lead sponsor of 339 studies on the registry; 37 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 17 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Diagnosis of peripheral T-cell non-Hodgkin's lymphoma
The following histologies are not eligible:
ALCL with CD30, ALK, and EMA expression
Adequate samples (e.g., core biopsies, especially multiple core biopsies) from the original diagnostic specimen available
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
VP-16 (Etoposide) 40 mg/m2 IV Days 1-4 Methyl Prednisolone 250 mg IV Days 1-4 Cisplatin 25 mg/m2 IV Days 1-4 Gemcitabine 1,000 mg/m2 IV Day 1
Drug: cisplatin · Drug: etoposide · Drug: gemcitabine · Drug: methylprednisolone
2-year Overall Survival Rate
The overall survival rate is the percentage of patients who are alive 2 years after registration to the study. Overall survival is defined as the time between study registration and death due to any cause.
Time frame: 0-2 years
2-year Progression-free Survival Rate
Progression-free survival rate is the percentage of patients who do not show signs of progression at 2 years after registration to the study, including those whose disease has either completely or partially responded to treatment, or those whose disease is stable. Progression-free survival is defined as the time between study registration and documented progression, or death if no progression was observed.
Time frame: 0-2 years
Response Rate
Complete Response(CR) is a complete disappearance of all disease with the exception of nodes. No new lesions. previously enlarged organs must have regressed and not be palpable. Bone marrow(BM) must be negative if positive at baseline. Normalization of markers. CR Unconfirmed (CRU) does not qualify for CR above, due to a residual nodal mass or an indeterminate BM. Partial Response(PR) is a 50% decrease in the sum of products of greatest diameters (SPD) for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes.
Time frame: up to 3 years or time of disease progression
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.
Time frame: up to 18 weeks of protocol treatment
| Milestone | PEGS |
|---|---|
| Started | 34 |
| Eligible | 33 |
| Eligible and began protocol therapy | 33 |
| Completed | 21 |
| Not completed | 13 |
| Withdrew: Adverse event | 2 |
| Withdrew: Progression | 6 |
| Withdrew: Death | 2 |
| Withdrew: Not protocol specified | 2 |
| Withdrew: Not eligible | 1 |
The overall survival rate is the percentage of patients who are alive 2 years after registration to the study. Overall survival is defined as the time between study registration and death due to any cause.
| percentage of participants | PEGS |
|---|---|
| 2-year Overall Survival Rate | 31 (8 to 54) |
Progression-free survival rate is the percentage of patients who do not show signs of progression at 2 years after registration to the study, including those whose disease has either completely or partially responded to treatment, or those whose disease is stable. Progression-free survival is defined as the time between study registration and documented progression, or death if no progression was observed.
| percentage of participants | PEGS |
|---|---|
| 2-year Progression-free Survival Rate | 12 (0.1 to 31) |
Complete Response(CR) is a complete disappearance of all disease with the exception of nodes. No new lesions. previously enlarged organs must have regressed and not be palpable. Bone marrow(BM) must be negative if positive at baseline. Normalization of markers. CR Unconfirmed (CRU) does not qualify for CR above, due to a residual nodal mass or an indeterminate BM. Partial Response(PR) is a 50% decrease in the sum of products of greatest diameters (SPD) for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes.
| participants | PEGS |
|---|---|
| Complete Response | 6 |
| Unconfirmed Complete Response | 2 |
| Partial Response | 5 |
| No Response | 20 |
Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.
| Participants | PEGS |
|---|---|
| Albumin, serum-low (hypoalbuminemia) | 1 |
| Allergic reaction/hypersensitivity | 1 |
| Anorexia | 2 |
| Ataxia (incoordination) | 1 |
| Auditory/Ear-Other (Specify) | 1 |
| Blood/Bone Marrow-Other (Specify) | 1 |
| Colitis, infectious (e.g., Clostridium difficile) | 2 |
| Creatinine | 2 |
| Diarrhea | 2 |
| Dysphagia (difficulty swallowing) | 1 |
| Dyspnea (shortness of breath) | 1 |
| Fatigue (asthenia, lethargy, malaise) | 2 |
| Febrile neutropenia | 4 |
| Gastrointestinal-Other (Specify) | 1 |
| Glucose, serum-high (hyperglycemia) | 4 |
| Glucose, serum-low (hypoglycemia) | 1 |
| Hemoglobin | 9 |
| Hemorrhage, CNS | 1 |
| Hypotension | 2 |
| Incontinence, anal | 1 |
| Inf (clin/microbio) w/Gr 3-4 neuts - Blood | 1 |
| Inf (clin/microbio) w/Gr 3-4 neuts - Colon | 1 |
| Inf w/normal ANC or Gr 1-2 neutrophils - Bladder | 1 |
| Inf w/normal ANC or Gr 1-2 neutrophils - Lung | 1 |
| Leukocytes (total WBC) | 8 |
| Lymphopenia | 7 |
| Magnesium, serum-low (hypomagnesemia) | 2 |
| Nausea | 1 |
| Neurology-Other (Specify) | 1 |
| Neuropathy: motor | 1 |
| Neuropathy: sensory | 2 |
| Neutrophils/granulocytes (ANC/AGC) | 16 |
| Pain - Abdomen NOS | 1 |
| Platelets | 8 |
| Potassium, serum-low (hypokalemia) | 1 |
| Renal failure | 2 |
| Sodium, serum-low (hyponatremia) | 2 |
| Thrombotic microangiopathy | 1 |
| Tinnitus | 1 |
| Tumor lysis syndrome | 1 |
| Uric acid, serum-high (hyperuricemia) | 1 |
Collected over up to 18 weeks of protocol treatment. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| PEGS | — | 5/33 (15.2%) | 33/33 (100%) |
| Event | PEGS |
|---|---|
| Thrombotic microangiopathyBlood and lymphatic system disorders | 1/33 |
| Inf (clin/microbio) w/Gr 3-4 neuts - BloodInfections and infestations | 1/33 |
| Sodium, serum-low (hyponatremia)Metabolism and nutrition disorders | 1/33 |
| Death - Disease progression NOSNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/33 |
| Hemorrhage, CNSNervous system disorders | 1/33 |
| Event | PEGS |
|---|---|
| HemoglobinBlood and lymphatic system disorders | 28/33 |
| NauseaGastrointestinal disorders | 24/33 |
| Fatigue (asthenia, lethargy, malaise)General disorders | 21/33 |
| Neutrophils/granulocytes (ANC/AGC)Investigations | 21/33 |
| Leukocytes (total WBC)Investigations | 20/33 |
| PlateletsInvestigations | 18/33 |
| Edema: limbGeneral disorders | 16/33 |
| CreatinineInvestigations | 15/33 |
| Glucose, serum-high (hyperglycemia)Metabolism and nutrition disorders | 15/33 |
| Hair loss/Alopecia (scalp or body)Skin and subcutaneous tissue disorders | 15/33 |
Peripheral T-cell lymphomas (PTCLs) with stage II bulky, III or IV with extra-nodal, nodal and transformed cutaneous presentations were eligible.
| Age, Continuous(years) | PEGS |
|---|---|
| Median | 60 (20 to 92) |
| Sex: Female, Male(Participants) | PEGS |
|---|---|
| Female | 11 |
| Male | 22 |
| Ethnicity (NIH/OMB)(Participants) | PEGS |
|---|---|
| Hispanic or Latino | 2 |
| Not Hispanic or Latino | 31 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | PEGS |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 4 |
| White | 28 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
This study is completed, as verified in Sep 2014. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Cisplatin · Etoposide · Gemcitabine
SWOG Cancer Research Network →