Study of Motexafin Gadolinium and Docetaxel for Advanced Cancer

Pharmacyclics

Status and phase: Completed; Phase 1

Conditions: Lung Neoplasms; Ovarian Neoplasms; Prostatic Neoplasms; Breast Neoplasms; Gastrointestinal Neoplasms

Treatments: Drug: Motexafin Gadolinium

Study type: Interventional

Funder types: Industry

Identifiers

NCT00120939

PCYC-0212

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)