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Completed

NCT Number: NCT00120939

Study of Motexafin Gadolinium and Docetaxel for Advanced Cancer

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.

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Key information

Conditions

Breast Neoplasms Adnexal Diseases Astrocytoma Breast Diseases Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Disease Attributes Endocrine Gland Neoplasms Endocrine System Diseases Endometrial Neoplasms Esophageal Diseases Esophageal Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Diseases, Male Genital Neoplasms, Female Genital Neoplasms, Male Glioblastoma Glioma Gonadal Disorders Head and Neck Neoplasms Intestinal Diseases Intestinal Neoplasms Kidney Diseases Kidney Neoplasms Lung Diseases Lung Neoplasms Male Urogenital Diseases Neoplasm Metastasis Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neoplastic Processes Neuroectodermal Tumors Ovarian Diseases Ovarian Neoplasms Pancreatic Diseases Pancreatic Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Prostatic Diseases Prostatic Neoplasms Rectal Diseases Recurrence Respiratory Tract Diseases Respiratory Tract Neoplasms Skin Diseases Skin and Connective Tissue Diseases Stomach Diseases Stomach Neoplasms Thoracic Neoplasms Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

motexafin gadolinium

Drug

Primary outcomes

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

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

Pharmacyclics LLC.

Industry

Registry information

Official study title

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

Important dates

First posted
Jul 19, 2005
Registry last updated
Apr 3, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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