Expired Study
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Pittsburgh, Pennsylvania 15213


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.


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


Study is Available At:


Original ID:

PCYC-0212


NCT ID:

NCT00120939


Secondary ID:


Study Acronym:


Brief Title:

Study of Motexafin Gadolinium and Docetaxel for Advanced Cancer


Official Title:

Phase I Trial of Motexafin Gadolinium (MGd) and Docetaxel Chemotherapy in the Treatment of Advanced Solid Tumors


Overall Status:

Completed


Study Phase:

Phase 1


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Pharmacyclics


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Non-Randomized, Endpoint Classificati


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

25


Enrollment Type:


Overall Contact Information

Official Name:Gurkamal Chatta, MD
Principal Investigator
University of Pittsburgh

Study Dates

Verification Date:May 2007
Last Changed Date:April 2, 2009
First Received Date:July 12, 2005

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Tumor response rate 8, 16 and 24 weeks, and common PK parameters at 24 weeks
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Determine the Dose Limiting Toxicity at 8 weeks (2 cycles), and the Maximum Tolerated Dose at 24 weeks.
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Motexafin Gadolinium

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Pharmacyclics

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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