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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2012-00318 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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You are being asked to take part in this research study because you are going to be treated with oxaliplatin chemotherapy as part of your standard care. Oxaliplatin commonly causes neuropathy (numbing, tingling and/or pain).The purpose of this study is to compare the effects, good and/or bad, of venlafaxine with a placebo (an inactive agent) on oxaliplatin-induced neuropathy (numbing, tingling and/or pain)
PRIMARY OBJECTIVES:
I. To explore whether venlafaxine can prevent or ameliorate chronic, cumulative neurotoxicity associated with oxaliplatin in cancer patients receiving oxaliplatin, fluorouracil, leucovorin calcium (FOLFOX).
SECONDARY OBJECTIVES:
I. To explore whether venlafaxine can ameliorate acute neuropathy associated with oxaliplatin.
TERTIARY OBJECTIVES:
I. To explore whether venlafaxine can increase the cumulative oxaliplatin doses that can be delivered without dose-limiting chronic neurotoxicity.
II. To explore whether venlafaxine causes adverse events in this setting. III. To explore whether the neuropathy data provided by the Rydel-Seiffer graduated tuning fork is consistent with patient-reported outcome (PRO) measures of chemotherapy-induced peripheral neuropathy (CIPN) and whether this tool might cause different results in patients receiving venlafaxine versus placebo.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive venlafaxine orally (PO) twice daily (BID) beginning on day 1 of and continuing through completion of FOLFOX.
ARM II: Patients receive placebo PO BID beginning on day 1 of and continuing through completion of FOLFOX.
After completion of study treatment, patients are followed up at 1, 3, 6, 12, and 18 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (management of therapy complications) | Experimental | Patients receive venlafaxine PO BID beginning on day 1 of and continuing through completion of FOLFOX. |
|
| Arm II (placebo) | Placebo Comparator | Patients receive placebo PO BID beginning on day 1 of and continuing through completion of FOLFOX. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| venlafaxine | Drug | Given PO |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cycle 1 Sensory Neuropathy Score (Items 31-36, 39, 40 and 48) of the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-CIPN20 | The EORTC QLQ-CIPN20 sensory neuropathy score will be calculated using the standard algorithm of EORTC QLQ-CIPN20 and transformed into a 0-100 point scale, where high scores meant less symptom burden. The changes of sensory neuropathy from baseline will be derived by subtracting the baseline score from the sensory neuropathy scores at each cycle of evaluation. | Up to 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Cycle 1 Acute Neuropathy as Measured by EORTC QLQ CIPN20 Motor Subscale (Items 37, 38, 41-45 and 49), and Autonomic Scale (Items 46, 47, 50) | The EORTC QLQ-CIPN20 motor and autonomic neuropathy scores will be calculated using the standard algorithm of EORTC QLQ-CIPN20 and transformed into a 0-100 point scale, where high scores meant less symptom burden. The changes of sensory neuropathy from baseline will be derived by subtracting the baseline score from the sensory neuropathy scores at each cycle of evaluation. |
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Inclusion Criteria:
Scheduled to receive FOLFOX chemotherapy with individual oxaliplatin doses of 85 mg/m^2 per cycle given in 2 week cycles (e.g. modified [m] FOLFOX6 or FOLFOX4) Adequate complete blood count (CBC) and creatinine values (per attending physician) obtained =< 28 days prior to registration Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0, 1 or 2 Negative pregnancy test done =< 7 days prior to registration, for women of childbearing potential Ability to complete questionnaire(s) by themselves or with assistance Life expectancy >= 4 months Strong inhibitors of CYP3A4: > 5-fold increase in the plasma area under the curve (AUC) values or more than 80 % decrease in clearance
Exclusion Criteria:
Any of the following:
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| Name | Affiliation | Role |
|---|---|---|
| Charles Loprinzi | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26248652 | Derived | Zimmerman C, Atherton PJ, Pachman D, Seisler D, Wagner-Johnston N, Dakhil S, Lafky JM, Qin R, Grothey A, Loprinzi CL. MC11C4: a pilot randomized, placebo-controlled, double-blind study of venlafaxine to prevent oxaliplatin-induced neuropathy. Support Care Cancer. 2016 Mar;24(3):1071-8. doi: 10.1007/s00520-015-2876-5. Epub 2015 Aug 8. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm I (Venlafaxine) | Patients receive venlafaxine PO BID beginning on day 1 of and continuing through completion of FOLFOX. |
| FG001 | Arm II (Placebo) | Patients receive placebo PO BID beginning on day 1 of and continuing through completion of FOLFOX. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Patients summarized in the baseline characteristics table exclude ineligible and patient withdrawals.
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm I (Venlafaxine) | Patients receive venlafaxine PO BID beginning on day 1 of and continuing through completion of FOLFOX. |
| BG001 | Arm II (Placebo) | Patients receive placebo PO BID beginning on day 1 of and continuing through completion of FOLFOX. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Cycle 1 Sensory Neuropathy Score (Items 31-36, 39, 40 and 48) of the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-CIPN20 | The EORTC QLQ-CIPN20 sensory neuropathy score will be calculated using the standard algorithm of EORTC QLQ-CIPN20 and transformed into a 0-100 point scale, where high scores meant less symptom burden. The changes of sensory neuropathy from baseline will be derived by subtracting the baseline score from the sensory neuropathy scores at each cycle of evaluation. | Patients who completed the (QLQ)-CIPN20 Sensory neuropathy items at cycle 1 are included in this analysis. | Posted | Mean | Standard Deviation | score on a scale | Up to 2 weeks |
|
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All patients who received treatment and submitted an AE form are included in the summary below.
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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 | Arm I (Venlafaxine) | Patients receive venlafaxine PO BID beginning on day 1 of and continuing through completion of FOLFOX. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Colonic obstruction | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA 12 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Charles L. Loprinzi, MD | Mayo Clinic | 507-284-3731 | cloprinzi@mayo.edu |
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| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| ID | Term |
|---|---|
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000069470 | Venlafaxine Hydrochloride |
| ID | Term |
|---|---|
| D003511 | Cyclohexanols |
| D000441 | Hexanols |
| D005233 | Fatty Alcohols |
| D000438 | Alcohols |
| D009930 |
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| placebo | Drug | Given PO |
|
|
| questionnaire administration | Other | Ancillary studies |
|
| quality-of-life assessment | Other | Ancillary studies |
|
|
| Up to 2 weeks |
| Disease progression |
|
| Withdrawal by Subject |
|
| Alternative treatment |
|
| Ineligible patient |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Arm II (Placebo) | Patients receive placebo PO BID beginning on day 1 of and continuing through completion of FOLFOX. |
|
|
|
| Secondary | Cycle 1 Acute Neuropathy as Measured by EORTC QLQ CIPN20 Motor Subscale (Items 37, 38, 41-45 and 49), and Autonomic Scale (Items 46, 47, 50) | The EORTC QLQ-CIPN20 motor and autonomic neuropathy scores will be calculated using the standard algorithm of EORTC QLQ-CIPN20 and transformed into a 0-100 point scale, where high scores meant less symptom burden. The changes of sensory neuropathy from baseline will be derived by subtracting the baseline score from the sensory neuropathy scores at each cycle of evaluation. | There were a few Venlafaxine patients who completed the items for the motor subscale but did not complete the items for autonomic subscale in cycle 1 and thus the number analyzed for each subscale is different on the venlafaxine arm. | Posted | Mean | Standard Deviation | score on a scale | Up to 2 weeks |
|
|
|
|
| 1 |
| 24 |
| 2 |
| 24 |
| 21 |
| 24 |
| EG001 | Arm II (Placebo) | Patients receive placebo PO BID beginning on day 1 of and continuing through completion of FOLFOX. | 1 | 25 | 2 | 25 | 20 | 25 |
| Diarrhea | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
|
| Edema limbs | General disorders | MedDRA 12 | Systematic Assessment |
|
| Catheter related infection | Infections and infestations | MedDRA 12 | Systematic Assessment |
|
| Hypokalemia | Metabolism and nutrition disorders | MedDRA 12 | Systematic Assessment |
|
| Metabolism and nutrition disorders - Other, specify | Metabolism and nutrition disorders | MedDRA 12 | Systematic Assessment |
|
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12 | Systematic Assessment |
|
| Hematoma | Vascular disorders | MedDRA 12 | Systematic Assessment |
|
| Thromboembolic event | Vascular disorders | MedDRA 12 | Systematic Assessment |
|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 12 | Systematic Assessment |
|
| Lower gastrointestinal hemorrhage | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
|
| Mucositis oral | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 12 | Systematic Assessment |
|
| Allergic reaction | Immune system disorders | MedDRA 12 | Systematic Assessment |
|
| Anaphylaxis | Immune system disorders | MedDRA 12 | Systematic Assessment |
|
| Infections and infestations - Other, specify | Infections and infestations | MedDRA 12 | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA 12 | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA 12 | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA 12 | Systematic Assessment |
|
| Weight loss | Investigations | MedDRA 12 | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA 12 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 12 | Systematic Assessment |
|
| Peripheral motor neuropathy | Nervous system disorders | MedDRA 12 | Systematic Assessment |
|
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 12 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 12 | Systematic Assessment |
|
| Agitation | Psychiatric disorders | MedDRA 12 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 12 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 12 | Systematic Assessment |
|
| Superficial thrombophlebitis | Vascular disorders | MedDRA 12 | Systematic Assessment |
|
| Thromboembolic event | Vascular disorders | MedDRA 12 | Systematic Assessment |
|
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| Organic Chemicals |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D000588 | Amines |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D008055 | Lipids |
| Autonomic subscale |
|
|
| 0.89 |
| Superiority |