Clinical trial · Interventional

Taxoprexin Treatment for Advanced Skin Melanoma

Phase II Open-Label Study of Weekly Taxoprexin (DHA-paclitaxel) Injection as First Line Treatment of Patients With Metastatic Non-choroidal Melanoma

NCT00249262CI-TRIAL-00095832completedPhase 2ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

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 malignant 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 for 5 weeks
interventionNames
1. 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 malignant skin/mucosal (non-choroidal) melanoma, and documented metastatic disease.
2. Patients must have at least one measurable lesion.
3. Patients must not have received prior systemic chemotherapy for metastatic disease. 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. Patients must have Eastern Cooperative Oncology Group performance status of 0-2.
7. Patients must be \> 13 years of age. The safety of Taxoprexin has not been adequately studied in younger patients.
8. Patients must have adequate liver and renal function.
9. Patients must have adequate bone marrow function.
10. Life expectancy of at least 3 months
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.

Exclusion Criteria:

1. Patients who have received prior therapy with any taxane.
2. Patients whose primary site was 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.

References

Publications (0)

Data not yet available

No reference posted for this study.