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Study of Motexafin Gadolinium and Docetaxel for Advanced Solid Tumors

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ClinicalTrials.gov Identifier: NCT00080041
Recruitment Status : Completed
First Posted : March 23, 2004
Last Update Posted : May 15, 2007
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Breast Neoplasms Ovarian Neoplasms Prostatic Neoplasms Lung Neoplasms Drug: Motexafin Gadolinium Injection Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
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 Administered at 3-Week Intervals for Advanced Solid Tumors

Arms and Interventions

Outcome Measures

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

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

Eligibility Criteria

Information from the National Library of Medicine

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

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


  • 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

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): NCT00080041

United States, New York
University of Rochester Cancer Center
Rochester, New York, United States
Sponsors and Collaborators
Pharmacyclics LLC.
More Information

ClinicalTrials.gov Identifier: NCT00080041     History of Changes
Other Study ID Numbers: PCYC-0214
First Posted: March 23, 2004    Key Record Dates
Last Update Posted: May 15, 2007
Last Verified: May 2007

Keywords provided by Pharmacyclics LLC.:
Antineoplastic Combined Chemotherapy Protocols

Additional relevant MeSH terms:
Breast Neoplasms
Prostatic Neoplasms
Lung Neoplasms
Ovarian 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
Motexafin gadolinium
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action