Study of Motexafin Gadolinium and Docetaxel for Advanced Cancer

NCT00120939CompletedPHASE1INTERVENTIONAL

Summary

Key Facts

Lead Sponsor

Pharmacyclics LLC.

Enrollment

25

Study Type

INTERVENTIONAL

Official Title

Phase I Trial of Motexafin Gadolinium (MGd) and Docetaxel Chemotherapy in the Treatment of Advanced Solid Tumors

Interventions

Motexafin Gadolinium

Conditions

Breast NeoplasmsOvarian NeoplasmsProstatic NeoplasmsLung NeoplasmsGastrointestinal Neoplasms

Eligibility

Age Range

18 Years+

Sex

ALL

Inclusion Criteria:

* At least 18 years old
* Metastatic, or unresectable solid tumors from breast, head, and neck, gastrointestinal, genitourinary, lung, or ovarian cancer or recurrent glioblastoma multiforme
* ECOG performance status score either 0, 1, or 2
* Willing and able to provide written informed consent

Exclusion Criteria:

* Greater than two prior cytotoxic regimens
* Laboratory values showing adequate function of bone marrow, liver, and kidneys
* Uncontrolled hypertension
* Known sensitivity to or intolerable adverse effects from taxanes (eg. paclitaxel, docetaxel) or polysorbate 80

Outcome Measures

Primary Outcomes

Determine the Dose Limiting Toxicity at 8 weeks (2 cycles), and the Maximum Tolerated Dose at 24 weeks.

Secondary Outcomes

Tumor response rate 8, 16 and 24 weeks, and common PK parameters at 24 weeks

Locations

University of Pittsburgh Medical Center, Pittsburgh, United States