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Temozolomide and Sorafenib in Treating Patients With Metastatic or Unresectable Melanoma
Phase 2 trial testing sorafenib tosylate in Melanoma (Skin) in 169 participants. Completed in 26 July 2009.
| Lead sponsor | Abramson Cancer Center at Penn Medicine |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 169 |
| Start date | 1 January 2005 |
| Primary completion | 21 December 2008 |
| Estimated completion | 26 July 2009 |
| Sites | 1 location across United States |
Abramson Cancer Center at Penn Medicine — full company profile →
Adults 18 to 120, any sex, with Melanoma (Skin). Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
| Group | Value | 95% CI |
|---|---|---|
| Arm A | 18 | |
| Arm B | 15 | |
| Arm C | 4 | |
| Arm D | 12 |
Response Rate as defined by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
| Group | Value | 95% CI |
|---|---|---|
| Arm A | 8 | |
| Arm B | 6 | |
| Arm C | 0 | |
| Arm D | 8 |
| Group | Value | 95% CI |
|---|---|---|
| Arm A | 12 | |
| Arm B | 18 | |
| Arm C | 5 | |
| Arm D | 17 |
Time frame: 4 years. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Arm A | Arm B | Arm C | Arm D |
|---|---|---|---|---|---|
| constipation | Gastrointestinal disorders | — | — | — | — |
| delayed wound healing | Metabolism and nutrition disorders | — | — | — | — |
| CNS hemorrhage | Vascular disorders | — | — | — | — |
| dehydration | General disorders | — | — | — | — |
| GI perforation | Gastrointestinal disorders | — | — | — | — |
| Pulmonary embolism | Vascular disorders | — | — | — | — |
| aterial thrombus | Vascular disorders | — | — | — | — |
| Reaction | System | Arm A | Arm B | Arm C | Arm D |
|---|---|---|---|---|---|
| Fatigue | General disorders | — | — | — | — |
| lymphopenia | Blood and lymphatic system disorders | — | — | — | — |
| Hand/foot syndrome | Skin and subcutaneous tissue disorders | — | — | — | — |
| Rash | Skin and subcutaneous tissue disorders | — | — | — | — |
| Nausea | Gastrointestinal disorders | — | — | — | — |
| Diarrhea | Gastrointestinal disorders | — | — | — | — |
| Weight loss | Metabolism and nutrition disorders | — | — | — | — |
| anorexia | Metabolism and nutrition disorders | — | — | — | — |
| stomatitis | Skin and subcutaneous tissue disorders | — | — | — | — |
| alopecia | Skin and subcutaneous tissue disorders | — | — | — | — |
| Constipation | Gastrointestinal disorders | — | — | — | — |
| anemia | Blood and lymphatic system disorders | — | — | — | — |
| Thrombocytopenia | Blood and lymphatic system disorders | — | — | — | — |
| hypertension | Cardiac disorders | — | — | — | — |
| neutropenia | Blood and lymphatic system disorders | — | — | — | — |
| Myalgia | Musculoskeletal and connective tissue disorders | — | — | — | — |
| hoarseness | General disorders | — | — | — | — |
| abdominal pain | Gastrointestinal disorders | — | — | — | — |
| dehydration | Metabolism and nutrition disorders | — | — | — | — |
| Headache | Nervous system disorders | — | — | — | — |
Most-reported serious reactions: constipation, delayed wound healing, CNS hemorrhage, dehydration, GI perforation, Pulmonary embolism, aterial thrombus.
Data from ClinicalTrials.gov NCT00602576 adverse events section.
RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving temozolomide together with sorafenib may kill more tumor cells. PURPOSE: This randomized phase II trial is studying two different schedules of temozolomide when given together with sorafenib to compare how well they work in treating patients with metastatic or unresectable melanoma.
2 peer-reviewed publications reference this trial (live from Europe PMC):
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Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00602576.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing