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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00508326
First received: July 25, 2007
Last updated: July 27, 2012
Last verified: July 2012
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00508326     History of Changes
Other Study ID Numbers: 2005-0092
Study First Received: July 25, 2007
Last Updated: July 27, 2012
Health Authority: United States: Institutional Review Board

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
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 19, 2014