Study of Motexafin Gadolinium and Docetaxel for Advanced... | NCT00120939

Studies
Study of Motexafin Gadolinium and Docetaxel for Advanced Cancer

NCT00120939

Sponsor

Pharmacyclics LLC.

Status

Completed

Last Update Posted

Apr 3, 2009Estimated

Enrollment

Phase

Phase 1

Conditions

Breast Neoplasms
Ovarian Neoplasms
Prostatic Neoplasms
Lung Neoplasms
Gastrointestinal Neoplasms

Interventions

Motexafin Gadolinium

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Jul 12, 2005

First Submission Date that Met QC Criteria

Jul 12, 2005

First Posted Date

Jul 19, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 2, 2009

Last Update Posted Date

Apr 3, 2009Estimated

Description Module

Brief Summary

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.

Detailed Description

Not provided

Conditions Module

Conditions

Breast Neoplasms
Ovarian Neoplasms
Prostatic Neoplasms
Lung Neoplasms
Gastrointestinal Neoplasms

Keywords

Lung Cancer
Breast Cancer
Prostate Cancer
Ovarian Cancer
Head and Neck Cancer
Gastrointestinal Cancer
Metastatic Cancer
Advanced Cancer
Genitourinary Cancer
Glioblastoma Multiforme
Recurrent Cancer
Colon Cancer
Gastric Cancer
Stomach Cancer
Pancreatic Cancer
Esophageal Cancer
Throat Cancer
Bladder Cancer
Kidney Cancer
Renal Cancer
Cervical Cancer
Endometrial Cancer
Colorectal Cancer

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
Motexafin Gadolinium	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Determine the Dose Limiting Toxicity at 8 weeks (2 cycles), and the Maximum Tolerated Dose at 24 weeks.

Secondary Outcomes

Measure	Description	Time Frame
Tumor response rate 8, 16 and 24 weeks, and common PK parameters at 24 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gurkamal Chatta, MD	University of Pittsburgh Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Pittsburgh Medical Center		Pittsburgh	Pennsylvania	15213	United States

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms
D010051	Ovarian Neoplasms
D011471	Prostatic Neoplasms
D008175	Lung Neoplasms
D005770	Gastrointestinal Neoplasms
D006258	Head and Neck Neoplasms
D009362	Neoplasm Metastasis
D014565	Urogenital Neoplasms
D005909	Glioblastoma
D012008	Recurrence
D003110	Colonic Neoplasms
D013274	Stomach Neoplasms
D010190	Pancreatic Neoplasms
D004938	Esophageal Neoplasms
D001749	Urinary Bladder Neoplasms
D007680	Kidney Neoplasms
D002583	Uterine Cervical Neoplasms
D016889	Endometrial Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided