Study of Motexafin Gadolinium and Docetaxel for Advanced Cancer
This study has been completed.
Sponsor:
Pharmacyclics
Information provided by:
Pharmacyclics
ClinicalTrials.gov Identifier:
NCT00120939
First received: July 12, 2005
Last updated: April 2, 2009
Last verified: May 2007
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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.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Neoplasms Ovarian Neoplasms Prostatic Neoplasms Lung Neoplasms Gastrointestinal Neoplasms |
Drug: Motexafin Gadolinium |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase I Trial of Motexafin Gadolinium (MGd) and Docetaxel Chemotherapy in the Treatment of Advanced Solid Tumors |
Resource links provided by NLM:
Further study details as provided by Pharmacyclics:
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00120939
Locations
| United States, Pennsylvania | |
| University of Pittsburgh Medical Center | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
Sponsors and Collaborators
Pharmacyclics
Investigators
| Principal Investigator: | Gurkamal Chatta, MD | University of Pittsburgh |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00120939 History of Changes |
| Other Study ID Numbers: | PCYC-0212 |
| Study First Received: | July 12, 2005 |
| Last Updated: | April 2, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Pharmacyclics:
|
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 |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Lung Neoplasms Ovarian Neoplasms Prostatic Neoplasms Neoplasms by Site Breast Diseases Skin Diseases Digestive System Diseases Gastrointestinal Diseases Respiratory Tract Neoplasms Thoracic Neoplasms Lung Diseases |
Respiratory Tract Diseases Endocrine Gland Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders Genital Neoplasms, Male Genital Diseases, Male Prostatic Diseases Docetaxel Motexafin gadolinium Antineoplastic Agents |
ClinicalTrials.gov processed this record on May 22, 2013