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Study of Motexafin Gadolinium and Docetaxel for Advanced Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00120939
First Posted: July 19, 2005
Last Update Posted: April 3, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Pharmacyclics LLC.
  Purpose
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.

Condition Intervention Phase
Breast Neoplasms Ovarian Neoplasms Prostatic Neoplasms Lung Neoplasms Gastrointestinal Neoplasms Drug: Motexafin Gadolinium Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Trial of Motexafin Gadolinium (MGd) and Docetaxel Chemotherapy in the Treatment of Advanced Solid Tumors

Resource links provided by NLM:


Further study details as provided by Pharmacyclics LLC.:

Primary Outcome Measures:
  • Determine the Dose Limiting Toxicity at 8 weeks (2 cycles), and the Maximum Tolerated Dose at 24 weeks.

Secondary Outcome Measures:
  • Tumor response rate 8, 16 and 24 weeks, and common PK parameters at 24 weeks

Estimated Enrollment: 25
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00120939


Locations
United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
Pharmacyclics LLC.
Investigators
Principal Investigator: Gurkamal Chatta, MD University of Pittsburgh
  More Information

ClinicalTrials.gov Identifier: NCT00120939     History of Changes
Other Study ID Numbers: PCYC-0212
First Submitted: July 12, 2005
First Posted: July 19, 2005
Last Update Posted: April 3, 2009
Last Verified: May 2007

Keywords provided by Pharmacyclics LLC.:
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

Additional relevant MeSH terms:
Neoplasms
Breast Neoplasms
Prostatic Neoplasms
Lung Neoplasms
Ovarian Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Endocrine Gland Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Endocrine System Diseases
Gonadal Disorders
Digestive System Diseases
Gastrointestinal Diseases
Docetaxel
Motexafin gadolinium
Antineoplastic Agents