Study of Motexafin Gadolinium and Docetaxel for Advanced Cancer

This study has been completed.
Sponsor:
Information provided by:
Pharmacyclics
ClinicalTrials.gov Identifier:
NCT00120939
First received: July 12, 2005
Last updated: April 2, 2009
Last verified: May 2007
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00120939

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

No publications provided

ClinicalTrials.gov Identifier: NCT00120939     History of Changes
Other Study ID Numbers: PCYC-0212
Study First Received: July 12, 2005
Last Updated: April 2, 2009
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on July 29, 2014