Study of Motexafin Gadolinium and Docetaxel for Advanced Cancer

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00120939

Enrollment

Registered

2005-07-19

Start date

Unknown

Completion date

Unknown

Last updated

2009-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Neoplasms, Gastrointestinal Neoplasms, Lung Neoplasms, Ovarian Neoplasms, Prostatic Neoplasms

Keywords

Lung Cancer, Breast Cancer, Prostate Cancer, Ovarian Cancer, Head and Neck Cancer, Gastrointestinal Cancer, Metastatic Cancer, Advanced Cancer, Genitourinary Cancer, Glioblastoma Multiforme, Recurrent Cancer, Colon Cancer, Gastric Cancer, Stomach Cancer, Pancreatic Cancer, Esophageal Cancer, Throat Cancer, Bladder Cancer, Kidney Cancer, Renal Cancer, Cervical Cancer, Endometrial Cancer, Colorectal Cancer

Brief 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.

Interventions

DRUGMotexafin Gadolinium

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
Tumor response rate 8, 16 and 24 weeks, and common PK parameters at 24 weeks	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026