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


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

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Determine the Dose Limiting Toxicity at 3 weeks (1 cycle), and the Maximum Tolerated Dose at 24 weeks (6 cycles).

Authority:

United States: Food and Drug Administration

Study ID:

PCYC-0214

NCT ID:

NCT00080041

Start Date:

Completion Date:

Related Keywords:

  • Breast Neoplasms
  • Ovarian Neoplasms
  • Prostatic Neoplasms
  • Lung Neoplasms
  • Antineoplastic Combined Chemotherapy Protocols
  • Breast Neoplasms
  • Neoplasms
  • Lung Neoplasms
  • Ovarian Neoplasms
  • Prostatic Neoplasms

Name

Location

University of Rochester Cancer CenterRochester, New York  14642