Study of Motexafin Gadolinium and Docetaxel for Advanced Cancer

Phase 1CompletedNCT00120939

Pharmacyclics LLC.25 enrolled

Overview

The primary purpose of this study is to evaluate the safety, side effects, and dosage for Motexafin Gadolinium given with the chemotherapy drug docetaxel to patients with advanced cancers. Secondly, tumor response to the combined treatment, drug levels in the body, and drug interactions will be evaluated.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Breast Neoplasms Ovarian Neoplasms Prostatic Neoplasms Lung Neoplasms Gastrointestinal Neoplasms

Interventions

Motexafin GadoliniumDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Outcomes

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

Data from ClinicalTrials.gov

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