Study of Motexafin Gadolinium and Docetaxel for Advanced Solid Tumors

This study has been completed.

Sponsor:

Information provided by:

Pharmacyclics

ClinicalTrials.gov Identifier:

NCT00080041

First received: March 22, 2004

Last updated: May 11, 2007

Last verified: May 2007

History of Changes

Tracking Information
First Received Date ^ICMJE	March 22, 2004
Last Updated Date	May 11, 2007
Start Date ^ICMJE
Primary Completion Date
Current Primary Outcome Measures ^ICMJE (submitted: August 18, 2005)	Determine the Dose Limiting Toxicity at 3 weeks (1 cycle), and the Maximum Tolerated Dose at 24 weeks (6 cycles).
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00080041 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: August 18, 2005)	Frequency of tumor responses at weeks 6, 12 and 18.
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE
Original Other Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Study of Motexafin Gadolinium and Docetaxel for Advanced Solid Tumors
Official Title ^ICMJE	Phase I Trial of Motexafin Gadolinium (MGd) and Docetaxel Administered at 3-Week Intervals for Advanced Solid Tumors
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.
Detailed Description
Study Type ^ICMJE	Interventional
Study Phase	Phase 1
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Breast Neoplasms Ovarian Neoplasms Prostatic Neoplasms Lung Neoplasms
Intervention ^ICMJE	Drug: Motexafin Gadolinium Injection
Study Arm (s)
Publications *
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	20
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00080041
Other Study ID Numbers ^ICMJE	PCYC-0214
Has Data Monitoring Committee
Responsible Party
Study Sponsor ^ICMJE	Pharmacyclics
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Pharmacyclics
Verification Date	May 2007
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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