Study of Motexafin Gadolinium and Docetaxel for Advanced Solid Tumors

This study has been completed.
Sponsor:
Information provided by:
Pharmacyclics
ClinicalTrials.gov Identifier:
NCT00080041
First received: March 22, 2004
Last updated: May 11, 2007
Last verified: May 2007
  Purpose

The primary purpose of this study is to evaluate the safety, toxicities, and dosage for investigational drug Motexafin Gadolinium administered with docetaxel to patients with advanced solid tumors. Secondly, tumor response to the combined treatment will be evaluated.


Condition Intervention Phase
Breast Neoplasms
Ovarian Neoplasms
Prostatic Neoplasms
Lung Neoplasms
Drug: Motexafin Gadolinium Injection
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I Trial of Motexafin Gadolinium (MGd) and Docetaxel Administered at 3-Week Intervals for Advanced Solid Tumors

Resource links provided by NLM:


Further study details as provided by Pharmacyclics:

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

Secondary Outcome Measures:
  • Frequency of tumor responses at weeks 6, 12 and 18.

Estimated Enrollment: 20
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00080041

Locations
United States, New York
University of Rochester Cancer Center
Rochester, New York, United States
Sponsors and Collaborators
Pharmacyclics
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00080041     History of Changes
Other Study ID Numbers: PCYC-0214
Study First Received: March 22, 2004
Last Updated: May 11, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Pharmacyclics:
Antineoplastic Combined Chemotherapy Protocols

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms
Lung Neoplasms
Ovarian Neoplasms
Prostatic Neoplasms
Neoplasms by Site
Breast Diseases
Skin 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
Therapeutic Uses
Pharmacologic Actions
Photosensitizing Agents
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on April 15, 2014