Study of Motexafin Gadolinium and Docetaxel for Advanced Solid Tumors

Breast Neoplasms Clinical Trial

Official title:

Phase I Trial of Motexafin Gadolinium (MGd) and Docetaxel Administered at 3-Week Intervals for Advanced Solid Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00080041
• Other study ID #: PCYC-0214
• Status: Completed
• Phase: Phase 1
• First received: March 22, 2004
• Last updated: May 11, 2007

Study information

• Verified date: May 2007
• Source: Pharmacyclics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Neoplasms
• Lung Neoplasms
• Neoplasms
• Ovarian Neoplasms
• Prostatic Neoplasms

Intervention

Drug:
• Motexafin Gadolinium Injection

Locations

Country	Name	City	State
United States	University of Rochester Cancer Center	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
Pharmacyclics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine the Dose Limiting Toxicity at 3 weeks (1 cycle), and the Maximum Tolerated Dose at 24 weeks (6 cycles).
Secondary	Frequency of tumor responses at weeks 6, 12 and 18.