Pharmacokinetic, Safety and Efficacy Study of Nanoparticle Paclitaxel in Patients With Peritoneal Cancers

NCT00666991 | Completed Phase 1 DMC

• 1 other identifier: HSC#11140
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study is to evaluate the safety, pharmacokinetics and preliminary efficacy of an intraperitoneally administered suspension of nanoparticulate paclitaxel in patients with refractory malignancies principally confined to the peritoneal cavity.

Conditions

Peritoneal Neoplasms

Keywords

ovarian cancer; Mullerian tumors; peritoneal cavity carcinoma; gastrointestinal tract tumor; GI tract tumor; pancreatic cancer; colon cancer

Outcome Measures

Primary Outcomes (1)

• Determine maximum tolerated dose and to assess qualitative and quantitative toxicities

  Through last patient visit

Secondary Outcomes (2)

• Determine preliminary anti-tumor activity using RECIST criteria

  Through last patient visit

• Determine pharmacokinetics of intraperitoneal administration

  Up to 14 days following Cycles 1 and 2

Study Arms (6)

Nanotax, 50 mg/m2

EXPERIMENTAL

Nanoparticulate paclitaxel (Nanotax) administered via intraperitoneal infusion at a dose of 50 mg/m2 once every 28 days until progression or unacceptable toxicity

Drug: nanoparticulate paclitaxel

Nanotax, 82.5 mg/m2

EXPERIMENTAL

Nanoparticulate paclitaxel (Nanotax) administered via intraperitoneal infusion at a dose of 82.5 mg/m2 once every 28 days until progression or unacceptable toxicity

Drug: nanoparticulate paclitaxel

Nanotax, 125 mg/m2

EXPERIMENTAL

Nanoparticulate paclitaxel (Nanotax) administered via intraperitoneal infusion at a dose of 125 mg/m2 once every 28 days until progression or unacceptable toxicity

Drug: nanoparticulate paclitaxel

Nanotax, 175 mg/m2

EXPERIMENTAL

Nanoparticulate paclitaxel (Nanotax) administered via intraperitoneal infusion at a dose of 175 mg/m2 once every 28 days until progression or unacceptable toxicity

Drug: nanoparticulate paclitaxel

Nanotax, 225 mg/m2

EXPERIMENTAL

Nanoparticulate paclitaxel (Nanotax) administered via intraperitoneal infusion at a dose of 225 mg/m2 once every 28 days until progression or unacceptable toxicity

Drug: nanoparticulate paclitaxel

Nanotax 275 mg/m2

EXPERIMENTAL

Nanoparticulate paclitaxel (Nanotax) administered via intraperitoneal infusion at a dose of 275 mg/m2 once every 28 days until progression or unacceptable toxicity

Drug: nanoparticulate paclitaxel

Interventions

nanoparticulate paclitaxel DRUG

This is a Phase 1, dose-escalation study with 6 cohorts of 1 - 6 patients. Patients receive Nanotax via intraperitoneal infusion once every 28 days continuing on this treatment schedule until disease progression or unacceptable toxicity is experienced. Dosing cohorts are as follows: 50 mg/m2, 82.5 mg/m2, 125 mg/m2, 175 mg/m2, 225 mg/m2, and 275 mg/m2.

Also known as: Nanotax

Nanotax 275 mg/m2; Nanotax, 125 mg/m2; Nanotax, 175 mg/m2; Nanotax, 225 mg/m2; Nanotax, 50 mg/m2; Nanotax, 82.5 mg/m2

Eligibility Criteria

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

You may qualify if:

• Patients must be at least 18 years of age.
• Patients must have histologic or cytologic diagnosis of carcinoma predominantly confined to the peritoneal cavity.
• Patients must have failed all potentially curative therapy and have no other systemic treatment options available for extra-peritoneal disease. Patients with ovarian cancer that are platinum sensitive must have failed primary and at least one salvage regimen. Patients may undergo surgical debulking prior to entry into the trial.
• At least 28 days must have elapsed since completion of any other previous chemotherapy treatment received prior to registration in this study.
• Patients may have received prior abdominal surgery greater than 2 weeks prior to registration. Patients must have recovered from all effects of the surgical procedure.
• Patients must have a Zubrod Performance Status of 0 - 2.
• Patients must have a pretreatment granulocyte count greater than or equal to 1,500/microliter and platelet count greater than or equal to 100,000/microliter obtained within 14 days prior to registration.
• Patients must have adequate renal function as documented by a serum creatinine less than or equal to 1.5 times the institutional upper limit of normal obtained within 14 days prior to registration.
• Patients must have adequate hepatic function as documented by a bilirubin of less than or equal to 2 times the institutional upper limit of normal and an SGOT less than 5 times the institutional upper limit of normal obtained within 14 days prior to registration. Patients with hepatobiliary stents are eligible for this trial if the bilirubin meets the above parameter.
• There should be no plans for the patient to receive concomitant radiation therapy, hormonal therapy, or other chemotherapy for their tumor while on this protocol.

You may not qualify if:

• Patients with active inflammatory bowel disease or chronic diarrhea
• Patients with uncontrolled hypertension, unstable angina, symptomatic congestive heart failure, myocardial infarction within previous 6 months or serious uncontrolled cardiac arrhythmia
• Patients with active infection requiring systemic therapy
• Pregnant or nursing women
• Patients with Grade 2 or greater sensory neuropathy (by NCI Common Toxicity Criteria) at the time of study registration
• Patients taking concomitant medications demonstrated to inhibit or induce CYP3A4 or CYP2C8
• Patients with pre-existing conditions that prohibit the use of intravenous dexamethasone at the recommended dose

Sponsors & Collaborators

• CritiTech, Inc.: lead
• University of Kansas Medical Center: collaborator
• Beckloff Associates, Inc.: collaborator

Study Sites (3)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Cancer Center of Kansas

Wichita, Kansas, 67208, United States

Location

Peggy and Charles Stephenson Oklahoma Cancer Center

Oklahoma City, Oklahoma, 73104, United States

Location

MeSH Terms

Conditions

Peritoneal Neoplasms; Ovarian Neoplasms; Digestive System Neoplasms; Pancreatic Neoplasms; Colonic Neoplasms

Condition Hierarchy (Ancestors)

Abdominal Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Peritoneal Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Pancreatic Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Gary Johnson, M.D.

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

• Julia Chapman, M.D.

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

• Thomas K Schulz, M.D.

  Cancer Center of Kansas

  PRINCIPAL INVESTIGATOR

• Kathleen Moore, MD

  Peggy and Charles Stephenson Oklahoma 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: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2008
• First Posted: April 25, 2008
• Study Start: July 1, 2008
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: February 27, 2014

Record last verified: 2014-02

Locations

US (3)