ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Study of Motexafin Gadolinium and Docetaxel for Advanced Solid Tumors

This study has been completed.

Sponsored by: Pharmacyclics
Information provided by: Pharmacyclics
ClinicalTrials.gov Identifier: NCT00080041
  Purpose

The primary purpose of this study is to evaluate the safety, toxicities, and dosage for investigational drug Motexafin Gadolinium administered with docetaxel to patients with advanced solid tumors. Secondly, tumor response to the combined treatment will be evaluated.


Condition Intervention Phase
Breast Neoplasms
Ovarian Neoplasms
Prostatic Neoplasms
Lung Neoplasms
Drug: Motexafin Gadolinium Injection
Phase I

Genetics Home Reference related topics:   breast cancer   

MedlinePlus related topics:   Breast Cancer    Cancer    Lung Cancer    Ovarian Cancer    Prostate Cancer   

Drug Information available for:   Docetaxel    Motexafin gadolinium    Motexafin   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title:   Phase I Trial of Motexafin Gadolinium (MGd) and Docetaxel Administered at 3-Week Intervals for Advanced Solid Tumors

Further study details as provided by Pharmacyclics:

Primary Outcome Measures:
  • Determine the Dose Limiting Toxicity at 3 weeks (1 cycle), and the Maximum Tolerated Dose at 24 weeks (6 cycles).

Secondary Outcome Measures:
  • Frequency of tumor responses at weeks 6, 12 and 18.

Estimated Enrollment:   20

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • ≥ 18 years old
  • Histologically or cytologically confirmed diagnosis of cancer (i.e., Unresectable locally advanced or metastatic non-small-cell lung carcinoma (NSCLC) that had progressed during or after one or more chemotherapy regimens; Metastatic breast cancer; Hormone-refractory prostate cancer; Recurrent or refractory ovarian cancer; Sarcoma)
  • ECOG performance status score either 0 or 1
  • Willing and able to provide written informed consent

Exclusion Criteria:

Laboratory Values of:

  • Absolute neutrophil count < 2000/µL
  • Platelet count < 100,00/µL
  • AST or ALT > 1.5 x the upper limit of normal
  • Alkaline phosphatase > 5 x the upper limit of normal
  • Bilirubin > ULN
  • Creatinine > 2.0 mg/dL

and

  • Peripheral neuropathy NCI CTC Grade 3 or higher
  • Chemotherapy, radiation therapy, immunotherapy, or systemic biologic
  • anticancer therapy within 21 days before beginning study treatment
  • Known history of brain metastases or spinal cord compression
  • Uncontrolled hypertension
  • Myocardial infarction within 6 months before beginning study treatment
  • Unstable angina pectoris, uncontrolled congestive heart failure, or uncontrolled serious arrhythmias
  • Known sensitivity to or intolerable adverse effects from taxanes or polysorbate 80
  • Known history of porphyria (testing not required at screening)
  • Known history of glucose-6-phosphate dehydrogenase (G6PD) deficiency (testing not required at screening)
  • Known history of HIV infection (testing not required at screening)
  • Female who is pregnant or lactating (pregnancy test is required for all female patients of childbearing potential)
  • Female of childbearing potential or sexually active male unwilling to use adequate contraceptive protection
  • Physical or mental condition that makes patient unable to complete specified follow-up assessments
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00080041

Locations
United States, New York
University of Rochester Cancer Center    
      Rochester, New York, United States

Sponsors and Collaborators
Pharmacyclics
  More Information


Study ID Numbers:   PCYC-0214
First Received:   March 22, 2004
Last Updated:   May 11, 2007
ClinicalTrials.gov Identifier:   NCT00080041
Health Authority:   United States: Food and Drug Administration

Keywords provided by Pharmacyclics:
Antineoplastic Combined Chemotherapy Protocols  

Study placed in the following topic categories:
Thoracic Neoplasms
Ovarian cancer
Ovarian Neoplasms
Prostatic Diseases
Genital Neoplasms, Male
Skin Diseases
Gonadal Disorders
Genital Neoplasms, Female
Endocrine System Diseases
Breast Neoplasms
Urogenital Neoplasms
Ovarian Diseases
Motexafin gadolinium
Genital Diseases, Male
Docetaxel
Genital Diseases, Female
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Endocrinopathy
Prostatic Neoplasms
Breast Diseases
Endocrine Gland Neoplasms

Additional relevant MeSH terms:
Respiratory Tract Neoplasms
Photosensitizing Agents
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs
Dermatologic Agents
Pharmacologic Actions
Adnexal Diseases

ClinicalTrials.gov processed this record on November 30, 2008




Links to all studies - primarily for crawlers