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A Two-Stage Trial of STA-4783 in Combination With Weekly Paclitaxel for Treatment of Patients With Metastatic Melanoma


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Melanoma

Thank you

Trial Information

A Two-Stage Trial of STA-4783 in Combination With Weekly Paclitaxel for Treatment of Patients With Metastatic Melanoma


STA-4783 is a taxane potentiator, enhancing the effect of antitumor response of paclitaxel.
In an attempt to improve efficacy, paclitaxel is sometimes used in combination with other
anticancer agents. When paclitaxel is combined with other anticancer agents, although
response rate is usually increased, side effects are usually increased as well. There is an
urgent need for agents that can enhance the antitumor effects of paclitaxel without further
increasing undesirable side effects.


Inclusion Criteria:



- M or F 18 or older with histologically confirmed metastatic (Stage IV) melanoma of
cutaneous origin

- ECOG performance status of greater than or equal to 2

- Measurable disease per RECIST criteria

- Received no more than 1 regimen of prior chemotherapy (unlimited immunotherapy
regimens are allowed)

- At least 4 weeks have passed since last chemotherapy or immunotherapy

- At least 2 weeks have passed since last radiotherapy.

- Life expectancy of greater than 12 weeks

- Clinical lab values within protocol parameters

Exclusion Criteria:

- Female patients pregnant or lactating

- Female patients of childbearing potential not using or not willing to use effective
contraception

- Presence of a second malignancy other than nonmelanoma skin cancer

- Presence of a clinically significant and uncontrolled infection

- Presence of clinically significant arrythmias

- Presence of serious concurrent illness or other conditions that do not permit
adequate follow-up and compliance with protocol

- History of severe hypersensitivity reactions to taxanes

- Use of any investigational agents within 4 weeks prior to the first dose of study
drug

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Authority:

United States: Food and Drug Administration

Study ID:

4783-03

NCT ID:

NCT00084214

Start Date:

May 2004

Completion Date:

Related Keywords:

  • Melanoma
  • metastatic
  • increased antitumor effect
  • Melanoma

Name

Location

Hubert H. Humphrey Cancer CenterCoon Rapids, Minnesota  55433
Cancer Care CenterNew Albany, Indiana  47150
Genesis Cancer CenterHot Springs, Arkansas  71913
Scripps Cancer CenterLa Jolla, California  92037
Medical Oncology and Hematology, P.C.Hamden, Connecticut  06518
Virginia Cancer InstituteRichmond, Virginia  23230
Maine Center for Cancer Medicine & Blood DisordersScarborough, Maine  04074
Northern California Melanoma CenterSan Francisco, California  94109
Piedmont Oncology SpecialistsCharlotte, North Carolina  28207
Danville Hematology & Oncology, Inc.Danville, Virginia  24541
Joliet Oncology-Hematology Associates, Ltd.Flossmoor, Illinois  60422
Indiana Oncology Hematology ConsultantsIndianapolis, Indiana  46202
Univ Of Arkansas/Arkansas Research CenterLittle Rock, Arkansas  72205-7101
Cancer Institute Medical Group, IncSanta Monica, California  90404
Anschutz Cancer Pavillion - Univ Of ColoradoAurora, Colorado  80010
Hematology Oncology P.C.Stamford, Connecticut  06902-3628
Emory University - Winship Cancer InstituteAtlanta, Georgia  30322-1013
Research Institute Hawaii Pacific HealthHonolulu, Hawaii  96813
Oncology SpecialistsPark Ridge, Illinois  60068
Cancer Care Center Of Southern IndianaBloomington, Indiana  47403
Center For Cancer Care At Goshen HealthGoshen, Indiana  46527-0139
James Graham Brown Cancer Center - University Of LouisvilleLouisville, Kentucky  40202
Ellis Fischels Cancer Center - Univ Of MissouriColumbia, Missouri  65203
Mountainside Hospital, Suburban Surgical AssociatesSt. Louis, Missouri  63131
Odyssey Research and St. Alexius Medical CenterBismarck, North Dakota  58501
Providence Cancer CenterPortland, Oregon  97213-2933
Office of James Stark, MDPortsmouth, Virginia  23707
University of Wisconsin Medical SchoolMadison, Wisconsin  53792-0001