A Phase 2 interventional study of Doxorubicin, Rituxan, Cyclophosphamide, Vincristine and Prednisone in Non-Hodgkin's Lymphoma, sponsored by University of Southern California. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-08-10.
Sponsored by University of Southern California · Phase 2, Interventional, and Treatment
The current standard treatment for non-Hodgkin's lymphoma involves drugs called cyclophosphamide, doxorubicin, vincristine, prednisone and rituxan in a regimen called "R-CHOP." Using R-CHOP therapy, complete disappearance of disease is expected in over 50% of people. One of the active drugs in the R-CHOP regimen, doxorubicin, has previously been reformulated and been placed in a fatty bubble called a liposome. The reason for placing the drug in the liposome is that there is evidence that the liposome is better taken up by tumors. This liposomally encapsulated form of doxorubicin called Doxil has shown similar or better anti-tumor against certain tumors with reduced side effects. Doxil is FDA approved for ovarian cancer. However its use in non-Hodgkin's lymphoma is still investigational. By substituting Doxil for doxorubicin in the R-CHOP regimen, it is hoped this treatment will be better at shrinking tumors and with reduced side effects. The purpose of this study is to see how well the combination of Doxil, rituximab, cyclophosphamide, vincristine and prednisone (DR-COP) are in shrinking tumors in patients with non-Hodgkin's lymphoma.
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's enrollment of 68 is above the median of 40 across 4,508 interventional studies indexed under Lymphoma.
Browse Lymphoma studies →University of Southern California is the lead sponsor of 773 studies on the registry; 135 are open to participants now.
Of its 68 completed or terminated interventional studies of FDA-regulated products, 32 (47%) have results posted.
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Exclusion Criteria:
On cycle 1 patients receive Doxil 40 mg/m2 iv day 1 over a minimum of 60 min., Cyclophosphamide 750 mg/m2 iv day 1 over a minimum of 60 min., Vincristine 1.4 mg/m2 iv bolus day 1 (2.0 mg maximum) and Prednisone 100 mg po days 1-5. On cycle 2 until study completion patients receive Doxil 40 mg/m2 iv day 1, Rituxan 375 mg/m2 iv day 1, Cyclophosphamide 750 mg/m2 iv day 1, Vincristine 1.4 mg/m2 iv bolus day 1 (2.0 mg maximum) and Prednisone 100 mg po days 1-5 * 1 cycle = 21 days. * Continue treatment until 2 cycles beyond documentation of CR for a maximum of 8 cycles.
Drug: Doxorubicin, Rituxan, Cyclophosphamide, Vincristine and Prednisone
Cycle 1 Doxil 40 mg/m2 iv day 1 over a minimum of 60 min. Cyclophosphamide 750 mg/m2 iv day 1 over a minimum of 60 min. Vincristine 1.4 mg/m2 iv bolus day 1 (2.0 mg maximum). Prednisone 100 mg po days 1-5. Cycle 2 until study completion Doxil 40 mg/m2 iv day 1 Rituxan 375 mg/m2 iv day 1 Cyclophosphamide 750 mg/m2 iv day 1 Vincristine 1.4 mg/m2 iv bolus day 1 (2.0 mg maximum) Prednisone 100 mg po days 1-5 * 1 cycle = 21 days. * Continue treatment until 2 cycles beyond documentation of CR for a maximum of 8 cycles.
Percentage of Patients With Complete Response to the Combination Chemotherapy
Initial disease response tests will be performed after cycle 4 on all patients. Subsequent assessments after cycles 6 and/or 8 will depend on response. If after 4 cycles of therapy complete response or partial response has been documented, therapy will continue. If stable or progressive disease has been documented, the patient will be withdrawn from the study. Response to the study treatment will be determined according to the criteria proposed in the "Report of an International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas" by Cheson et al (23).
Time frame: At completion of cycle 4, 6, and 8
Number of Patients With Serious Adverse Events as a Measure of Safety and Tolerability
Summary of grade 3 or higher toxicities (per Common Toxicity Criteria version 2.0) which generally is described as severe adverse reaction or symptom.
Time frame: At end of every cycle
The study began recruiting in January 2003 and ended in December 2007. All subjects were seen and treated either at USC Norris Comprehensive Cancer Center or at LAC+USC Medical Center.
| Milestone | DR-COP |
|---|---|
| Started | 68 |
| Completed | 51 |
| Not completed | 17 |
| Withdrew: Adverse event | 9 |
| Withdrew: Death | 3 |
| Withdrew: Physician decision | 1 |
| Withdrew: Withdrawal by subject | 4 |
Initial disease response tests will be performed after cycle 4 on all patients. Subsequent assessments after cycles 6 and/or 8 will depend on response. If after 4 cycles of therapy complete response or partial response has been documented, therapy will continue. If stable or progressive disease has been documented, the patient will be withdrawn from the study. Response to the study treatment will be determined according to the criteria proposed in the "Report of an International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas" by Cheson et al (23).
| Percentage of participants | DR-COP |
|---|---|
| Complete Response | 75.0 |
| Partial Response | 23.0 |
Summary of grade 3 or higher toxicities (per Common Toxicity Criteria version 2.0) which generally is described as severe adverse reaction or symptom.
| Participants | DR-COP |
|---|---|
| Number of Patients With Serious Adverse Events as a Measure of Safety and Tolerability | 35 |
Collected over Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| DR-COP | 3/68 (4.4%) | 35/68 (51.5%) | 27/68 (39.7%) |
| Event | DR-COP |
|---|---|
| Neutrophils/granulocytes (ANC/AGC)Blood and lymphatic system disorders | 35/68 |
| HemoglobinBlood and lymphatic system disorders | 11/68 |
| Hand-foot skin reactionSkin and subcutaneous tissue disorders | 10/68 |
| Febrile neutropeniaInfections and infestations | 8/68 |
| InfectionInfections and infestations | 8/68 |
| Dyspnea (shortness of breath)Respiratory, thoracic and mediastinal disorders | 6/68 |
| Infection without neutropeniaInfections and infestations | 6/68 |
| PlateletsBlood and lymphatic system disorders | 5/68 |
| HypokalemiaMetabolism and nutrition disorders | 3/68 |
| SGOT (AST) (serum glutamic oxaloacetic transaminase)Hepatobiliary disorders | 3/68 |
| Event | DR-COP |
|---|---|
| PainGeneral disorders | 27/68 |
| AlopeciaSkin and subcutaneous tissue disorders | 24/68 |
| HemoglobinBlood and lymphatic system disorders | 23/68 |
| Fatigue (lethargy, malaise, asthenia)General disorders | 22/68 |
| NauseaGastrointestinal disorders | 22/68 |
| ConstipationGastrointestinal disorders | 19/68 |
| Neutrophils/granulocytes (ANC/AGC)Blood and lymphatic system disorders | 19/68 |
| Hand-foot skin reactionSkin and subcutaneous tissue disorders | 18/68 |
| Stomatitis/pharyngitis (oral/pharyngeal mucositis)Gastrointestinal disorders | 17/68 |
| AnorexiaMetabolism and nutrition disorders | 16/68 |
| Age, Categorical(Participants) | DR-COP |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 60 |
| >=65 years | 8 |
| Sex: Female, Male(Participants) | DR-COP |
|---|---|
| Female | 39 |
| Male | 29 |
| Ethnicity (NIH/OMB)(Participants) | DR-COP |
|---|---|
| Hispanic or Latino | 48 |
| Not Hispanic or Latino | 20 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | DR-COP |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 12 |
| Native Hawaiian or Other Pacific Islander | 1 |
| Black or African American | 0 |
| White | 7 |
| More than one race | 0 |
| Unknown or Not Reported | 48 |
| Region of Enrollment(participants) | DR-COP |
|---|---|
| United States | 68 |
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