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NCT00120939 Clinical Trial

Study of Motexafin Gadolinium and Docetaxel for Advanced Cancer

Breast Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00120939
Other study ID # PCYC-0212
Secondary ID
Status Completed
Phase Phase 1
First received July 12, 2005
Last updated April 2, 2009

Study information
Verified date May 2007
Source Pharmacyclics
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 25
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Motexafin Gadolinium

Locations
Country Name City State
United States University of Pittsburgh Medical Center Pittsburgh Pennsylvania

Sponsors (1)
Lead Sponsor Collaborator
Pharmacyclics

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Determine the Dose Limiting Toxicity at 8 weeks (2 cycles), and the Maximum Tolerated Dose at 24 weeks.
Secondary Tumor response rate 8, 16 and 24 weeks, and common PK parameters at 24 weeks
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