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Study of Docetaxel and Oxaliplatin in Metastatic Transitional Cell Cancer (TCC) of the Urothelial Tract
Phase 2 trial testing Docetaxel in Metastatic Transitional Cell Cancer of the Urothelial Tract in 22 participants. Completed in 2 December 2009.
| Lead sponsor | Leonard Appleman |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 22 |
| Start date | 17 December 2004 |
| Primary completion | 2 June 2009 |
| Estimated completion | 2 December 2009 |
| Sites | 1 location across United States |
Leonard Appleman
18 and older, any sex, with Metastatic Transitional Cell Cancer of the Urothelial Tract. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage of patients who experienced a greater than or equal to a 30% reduction in measurable disease, as per the RECIST criteria.
| Group | Value | 95% CI |
|---|---|---|
| Docetaxel and Oxaliplatin | 11 | 3 – 31 |
Time to progression (TTP) will be calculated as number of months from the date of first treatment to the date of disease progression or the date of death (disease-related causes) or the cut-off date.
| Group | Value | 95% CI |
|---|---|---|
| Docetaxel and Oxaliplatin | 3 | 0.2 – 5.8 |
Percentage of patients who achieved complete response, partial response and stable disease. DCR will be calculated from the first day of the first cycle to the date of metastatic or primary tumor relapse, or last contact date, or date of death (if death comes before disease progression), or data cut-off.
| Group | Value | 95% CI |
|---|---|---|
| Docetaxel and Oxaliplatin | 26.3 | 12 – 49 |
The overall survival will be calculated as the number of months from the date of first treatment until death or the cut-off date.
| Group | Value | 95% CI |
|---|---|---|
| Docetaxel and Oxaliplatin | 7 | 4.6 – 9.4 |
Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Docetaxel and Oxaliplatin |
|---|---|---|
| Diarrhea | Gastrointestinal disorders | — |
| Vomiting | Gastrointestinal disorders | — |
| Neutrophils/granulocytes (ANC/AGC) | Blood and lymphatic system disorders | — |
| Cardiovascular/Arrhythmia - Other | Cardiac disorders | — |
| Cardiac-ischemia/infarction | Cardiac disorders | — |
| Gastric ulcer (requires radiographic or endoscopic documentation) | Gastrointestinal disorders | — |
| Ileus (or neuroconstipation) | Gastrointestinal disorders | — |
| Gastrointestinal - Other | Gastrointestinal disorders | — |
| Diarrhea patients with a colostomy | Gastrointestinal disorders | — |
| Dehydration | General disorders | — |
| Dyspnea (shortness of breath) | Respiratory, thoracic and mediastinal disorders | — |
| Gastric ulcer | Gastrointestinal disorders | — |
| Hemoglobin | Blood and lymphatic system disorders | — |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | — |
| Infection with ANC or Grade 1 or 2 neutrophils, Lung (pneumonia) | Infections and infestations | — |
| Neurology-Other | Nervous system disorders | — |
| Pneumonitis/pulmonary infiltrates | Respiratory, thoracic and mediastinal disorders | — |
| Potassium, serum-low (hypokalemia) | Blood and lymphatic system disorders | — |
| Pulmonary - Other | Respiratory, thoracic and mediastinal disorders | — |
| Sodium, serum-low (hyponatremia) | Blood and lymphatic system disorders | — |
| Reaction | System | Docetaxel and Oxaliplatin |
|---|---|---|
| Fatigue (asthenia, lethargy, malaise) | General disorders | — |
| Hemoglobin | Blood and lymphatic system disorders | — |
| Neuropathy: sensory | Nervous system disorders | — |
| Nausea | Gastrointestinal disorders | — |
| Neutrophils/granulocytes (ANC/AGC) | Blood and lymphatic system disorders | — |
| Anorexia | Gastrointestinal disorders | — |
| Diarrhea | Gastrointestinal disorders | — |
| Vomiting | Gastrointestinal disorders | — |
| Leukocytes (total WBC) | Blood and lymphatic system disorders | — |
| Constipation | Gastrointestinal disorders | — |
| Edema: limb | Blood and lymphatic system disorders | — |
| Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L) | General disorders | — |
| Rash/desquamation | Skin and subcutaneous tissue disorders | — |
| Dehydration | Gastrointestinal disorders | — |
| Pain, Abdomen NOS | General disorders | — |
| Dyspnea (shortness of breath) | Respiratory, thoracic and mediastinal disorders | — |
| Platelets | Blood and lymphatic system disorders | — |
| Hair loss/alopecia (scalp or body) | Skin and subcutaneous tissue disorders | — |
| Injection site reaction/extravasation changes | Skin and subcutaneous tissue disorders | — |
| Gastrointestinal - Other (Specify, __) | Gastrointestinal disorders | — |
| Mucositis/stomatitis (clinical exam), Oral cavity | Gastrointestinal disorders | — |
| Neurology - Other (Specify, __) | Nervous system disorders | — |
| Pain, Back | General disorders | — |
| Pain, Muscle | General disorders | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — |
| Hypotension | Cardiac disorders | — |
| Insomnia | General disorders | — |
| Weight loss | General disorders | — |
| Alkaline phosphatase | Metabolism and nutrition disorders | — |
| Pain, Bone | General disorders | — |
| Pain, Extremity-limb | General disorders | — |
| Pain, Joint | General disorders | — |
| Pain, Vagina | General disorders | — |
| Renal/Genitourinary - Other (Specify, __) | Renal and urinary disorders | — |
| Phlebitis (including superficial thrombosis) | Vascular disorders | — |
Most-reported serious reactions: Diarrhea, Vomiting, Neutrophils/granulocytes (ANC/AGC), Cardiovascular/Arrhythmia - Other, Cardiac-ischemia/infarction, Gastric ulcer (requires radiographic or endoscopic documentation), Ileus (or neuroconstipation), Gastrointestinal - Other.
Data from ClinicalTrials.gov NCT03159143 adverse events section.
The purpose of this non-randomized Phase II trial was to evaluate the efficacy of a combination of docetaxel and oxaliplatin in patients with metastatic transitional cell cancer (TCC) of the urothelial tract. The primary endpoint was to assess response, as defined as a 25% reduction in measurable disease per the RECIST criteria. Measurable or evaluable objective response rate, time to disease progression and survival were also assessed.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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