Clinical trial · Interventional
Taxoprexin® Treatment for Advanced Eye Melanoma
Phase II Open-Label Study of Weekly Taxoprexin® (DHA-paclitaxel) Injection as Treatment of Patients With Metastatic Uveal (Choroidal) Malignant Melanoma
NCT00244816CI-TRIAL-00096761completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To evaluate objective response rate and duration of response to weekly Taxoprexin®. To evaluate the safety profile of weekly Taxoprexin® in this patient population. To evaluate overall survival in the same patient population. To evaluate time to disease progression, and the time to treatment failure in patients with metastatic choroidal melanoma being treated with weekly Taxoprexin® Injection.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Melanoma | Melanoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Taxoprexin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Taxoprexin
- description
- Taxoprexin 500 mg/m² intravenously every week
- interventionNames
- Drug: Taxoprexin
Primary outcomes (1)
- measure
- Percentage of Participants Who Achieved an Objective Complete Response (CR) or Partial Response (PR)
- timeFrame
- Assessed every 6 weeks, up to 24 months
- description
- Antitumor response was defined as the percentage of participants who achieved an objective response (Confirmed Response \[CR\] or Partial Response \[PR\]), confirmed by repeat assessments performed no less than 4 weeks after the criteria for response were first met. Response was based on the blinded radiological review using Response Evaluation Criteria in Solid Tumors (RECIST) response guidelines, Version 1.0. A complete response was defined as a disappearance of all target lesions determined by 2 consecutive observations not less than 4 weeks apart. Partial response was defined as a 30% decrease in the sum of the longest diameters (LD) of target lesions, taking as reference the baseline sum of LD determined by 2 consecutive observations not less than 4 weeks apart.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 13 Years
Show eligibility criteria text
Inclusion Criteria:
1. Patients must have histologic or cytologic confirmation of malignant eye melanoma, and documented metastatic disease.
2. Patients must have at least one unidimensionally measurable lesion.
3. Patients may be previously untreated or may have received one prior systemic chemotherapy regimen for metastatic disease. Patients may not have been treated previously with taxanes. Prior treatment with immunotherapy or vaccine therapy is allowed.
4. At least 6 weeks (42 days) since any prior immunotherapy, cytokine, biologic, vaccine or other therapy.
5. At least 4 weeks (28 days) since prior radiotherapy to \> 20% of the bone marrow and prior adjuvant chemotherapy.
6. Lesions being used to assess disease status may not have been radiated or if so, must have progressed during or after radiation therapy.
7. Patients must have Eastern Cooperative Oncology Group performance status of 0 - 2.
8. Patients must be at least 13 years of age.
9. Patients must have adequate liver and renal function.
10. Patients must have adequate bone marrow function.
11. Patients must sign an informed consent form indicating that they are aware of the investigational nature of this study and in keeping with the policies of the institution.
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Exclusion Criteria:
1. Patients who have received prior therapy with any taxane.
2. Patients whose site of primary melanoma is not in the choroid(eye).
3. Patients who have a past or current history of neoplasm other than the entry diagnosis, except for curatively treated non-melanoma skin cancer or carcinoma in situ of the cervix or other cancers treated for cure and with a disease-free survival longer than 5 years.
4. Patients with symptomatic brain metastasis (es).
5. Patients who are pregnant or nursing and patients who are not practicing an acceptable method of birth control. Patients may not breastfeed while on this study.
6. Patients with current active infections requiring anti-infectious treatment (e.g., antibiotics, antivirals, or antifungals).
7. Patients with current peripheral neuropathy of any etiology that is greater than grade one (1).
8. Patients with unstable or serious concurrent medical conditions are excluded.
9. Patients with a known hypersensitivity to Cremophor.
10. Patients with Gilbert's Syndrome.
11. Patients must not have had major surgery within the past 14 days.
12. Patients must not receive any concurrent chemotherapy, radiotherapy, or immunotherapy while on study.
13. Known HIV disease or infection.
\-References
Publications (0)
Data not yet available
No reference posted for this study.