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


Phase 1
18 Years
N/A
Not Enrolling
Both
Breast Neoplasms, Ovarian Neoplasms, Prostatic Neoplasms, Lung Neoplasms, Gastrointestinal Neoplasms

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Principal Investigator

Gurkamal Chatta, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Pittsburgh

Authority:

United States: Food and Drug Administration

Study ID:

PCYC-0212

NCT ID:

NCT00120939

Start Date:

Completion Date:

Related Keywords:

  • Breast Neoplasms
  • Ovarian Neoplasms
  • Prostatic Neoplasms
  • Lung Neoplasms
  • Gastrointestinal Neoplasms
  • 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
  • Breast Neoplasms
  • Neoplasms
  • Gastrointestinal Neoplasms
  • Digestive System Neoplasms
  • Lung Neoplasms
  • Ovarian Neoplasms
  • Prostatic Neoplasms

Name

Location

University of Pittsburgh Medical CenterPittsburgh, Pennsylvania  15213