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

NCT00508326 | Completed Phase 1

• 1 other identifier: 2005-0092
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Advanced Cancer

Keywords

Advanced Cancer; Solid Tumor; Liver Metastasis; Hepatic Artery Infusion; Liver; Paclitaxel; Taxol

Outcome Measures

Primary Outcomes (1)

• Maximum Tolerated Dose of Monthly Cytotoxic Intraarterial Hepatic Paclitaxel

  Monthly

Study Arms (1)

HAI Paclitaxel

EXPERIMENTAL

Paclitaxel via Hepatic Artery Infusion (HAI)

Drug: Paclitaxel

Interventions

Paclitaxel DRUG

Starting dose 150 mg/m\^2 HAI once every 4 weeks

Also known as: Taxol

HAI Paclitaxel

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with histologically confirmed diagnosis of advanced malignancy and liver involvement as dominant site of metastasis.
• Performance status ECOG \< or = 2 (Requires occasional assistance but is able to care for own needs).
• Adequate renal function (serum creatinine \< 2.0 mg/dL).
• Adequate hepatic function (Total bilirubin \< 2.0 mg/dL; ALT \</= 5 times upper normal reference value).
• Bone marrow function (ANC \>or =1.5 cells/mcL; PLT \> or = 100,000 cells/mcL).
• At least three weeks from previous therapy and complete recovery from all associated acute toxicities.
• Ability to fully read, comprehend, and sign informed consent forms.
• 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.
• 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.
• Patients of both genders, 13 year-old or older.

You may not qualify if:

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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• UT MD Anderson Cancer Center website

MeSH Terms

Interventions

Paclitaxel

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Apostolia M. Tsimberidou, MD, PhD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2007
• First Posted: July 27, 2007
• Study Start: October 1, 2005
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: July 30, 2012

Record last verified: 2012-07

Locations

US (1)