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Paclitaxel Administered by HAI to Patients With Advanced Cancer and Dominant Liver Involvement

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00508326
First Posted: July 27, 2007
Last Update Posted: July 30, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
  Purpose
The goal of this clinical research study is find the highest tolerated dose of paclitaxel that can be given directly into the liver of patients with advanced cancer involving the liver. Researchers also want to collect descriptive information on any effects the drug may have on tumor tissue.

Condition Intervention Phase
Advanced Cancer Drug: Paclitaxel Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Study of Paclitaxel Administered by Hepatic Artery Infusion to Patients With Advanced Cancer and Dominant Liver Involvement

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Maximum Tolerated Dose of Monthly Cytotoxic Intraarterial Hepatic Paclitaxel [ Time Frame: Monthly ]

Enrollment: 27
Study Start Date: October 2005
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HAI Paclitaxel
Paclitaxel via Hepatic Artery Infusion (HAI)
Drug: Paclitaxel
Starting dose 150 mg/m^2 HAI once every 4 weeks
Other Name: Taxol

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with histologically confirmed diagnosis of advanced malignancy and liver involvement as dominant site of metastasis.
  2. Performance status ECOG < or = 2 (Requires occasional assistance but is able to care for own needs).
  3. Adequate renal function (serum creatinine < 2.0 mg/dL).
  4. Adequate hepatic function (Total bilirubin < 2.0 mg/dL; ALT </= 5 times upper normal reference value).
  5. Bone marrow function (ANC >or =1.5 cells/mcL; PLT > or = 100,000 cells/mcL).
  6. At least three weeks from previous therapy and complete recovery from all associated acute toxicities.
  7. Ability to fully read, comprehend, and sign informed consent forms.
  8. All females in childbearing age must have a negative urine or serum HCG test unless prior hysterectomy or menopause. Women of childbearing potential and men must use effective birth control.
  9. Patients should be refractory to standard chemotherapy or have no conventional therapy that produces a CR rate of at least 10% or an increase in survival of at least three months.
  10. Patients of both genders, 13 year-old or older.

Exclusion Criteria:

  1. Clinical or radiographic evidence of ascites.
  2. Pregnant or breastfeeding females.
  3. Hypersensitivity to paclitaxel compounds.
  4. History of severe hypersensitivity reactions to products containing polyoxyethylated castor oil or Cremophor.
  5. Inability to complete informed consent process and adhere to protocol treatment plan and follow-up requirements.
  6. Untreatable bleeding diathesis.
  7. Portal vein thrombosis.
  8. Peripheral neuropathy > Grade 1 according to NCI CTC v.3.0: sensory alteration not interfering with function).
  9. Untreated (radiation therapy, chemotherapy, surgery or a combination of modalities) brain metastasis.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00508326


Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Apostolia M. Tsimberidou, MD, PhD M.D. Anderson Cancer Center
  More Information

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00508326     History of Changes
Other Study ID Numbers: 2005-0092
First Submitted: July 25, 2007
First Posted: July 27, 2007
Last Update Posted: July 30, 2012
Last Verified: July 2012

Keywords provided by M.D. Anderson Cancer Center:
Advanced Cancer
Solid Tumor
Liver Metastasis
Hepatic Artery Infusion
Liver
Paclitaxel
Taxol

Additional relevant MeSH terms:
Neoplasms
Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action