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Phase I Dose Escalation Study of N-acetylcysteine (NAC) Administered Intravenously (IV) in Conjunction With Intraperitoneal (IP) Administered Cisplatin and IV/IP Paclitaxel in Patients With Stage III or IV Ovarian Cancer


Phase 1
18 Years
75 Years
Not Enrolling
Female
Ovarian Carcinoma, Stage 3 or 4, Epithelial Ovarian Carcinoma, Primary Peritoneal Carcinoma

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Trial Information

Phase I Dose Escalation Study of N-acetylcysteine (NAC) Administered Intravenously (IV) in Conjunction With Intraperitoneal (IP) Administered Cisplatin and IV/IP Paclitaxel in Patients With Stage III or IV Ovarian Cancer


OBJECTIVES:

PRIMARY:

To determine the Maximum Tolerated Dose (MTD) and assess the toxicity of IV NAC in
conjunction with IP cisplatin and IV/IP paclitaxel in subjects with stage 3 or 4 epithelial
ovarian cancer that has been surgically debulked

SECONDARY:

- To describe tumor response in subjects receiving treatment for previously debulked
stage 3 or 4 epithelial ovarian cancer with IP cisplatin, IV/IP paclitaxel , and IV
NAC.

- To describe the incidence and severity of nephrotoxicity ( Creatinine Clearance [CrCl])
in subjects undergoing treatment for stage 3 or 4 epithelial ovarian cancer with IP
cisplatin, IV paclitaxel and IV NAC and who have had their disease surgically
debulked.

- To describe the incidence and severity of hearing loss in subjects undergoing treatment
for stage 3 or 4 epithelial ovarian cancer with IP cisplatin, IV/IP paclitaxel and IV
NAC and who have had their disease surgically debulked.

- To describe the incidence and severity of peripheral and autonomic neuropathy in
subjects undergoing treatment for stage 3 or 4 epithelial ovarian cancer with IP
cisplatin, IV/IP Taxol and IV NAC and who have had their disease surgically debulked.

OUTLINE:

Subjects will undergo chemotherapy for epithelial ovarian cancer with paclitaxel IV, 135
mg/m2 (Day 1) and IP cisplatin 100 mg/m2 (Day2), followed by Taxol IP, 60 mg/m2 (Day 8)
every 3 weeks for 6 courses. Sixty minutes prior to each course of IP cisplatin, IV NAC
(starting at 150 mg/kg) will be infused over 30 minutes. A dose escalation schema for NAC
will be followed. Toxicity to the therapy will be graded according to the Common
Terminology Criteria for Adverse Events.


Inclusion Criteria:



- Signed written informed consent in accordance with institutional guidelines

- Histologically confirmed diagnosis of stage 3 or 4 epithelial ovarian or primary
peritoneal carcinoma

- Have had debulking surgery with optimal tumor cytoreduction

- Standard treatment offered for ovarian cancer including systemic or intraperitoneal
cisplatin with systemic taxane-based chemotherapy

- Age ≥ 18 years to ≤ 75 years

- Laboratory testing within 14 days of registration:

- White blood cell count ≥ 2.5 x 103/mm3

- Absolute granulocyte count ≥ 1.2 x 103/mm3

- Platelets ≥ 100 x 103/mm3

- Creatinine < 1.8

- Bilirubin < 2.0

- SGOT/SGPT < 2.5 x institutional upper limits of normal

- Performance status must be ECOG < 2 (Karnofsky ≥ 50)

- Life expectancy of ≥ 60 days from the date of registration

Exclusion Criteria:

- Pregnant, positive beta hCG, or lactating

- History of clinically significant reactive airway disease

- Active significant cardiac disease as evidenced by New York Heart Association
Classification for CHF, Class III or IV

- Uncontrolled (over the last 30 days) clinically significant confounding medical
conditions

- Allergies or other contraindications to IP cisplatin, IV Taxol, or IV NAC.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the MTD and assess the toxicity of IV NAC

Outcome Description:

The MTD of IV NAC will be defined as one dose level below that which produces NCI CTC grade 3 or 4 non-hematologic toxicity in 20% of subjects. The toxicity of NAC can be differentiated from that of the chemotherapeutic drugs as the half-life of NAC is very short and adverse effects are seen either during or very soon after the administration of NAC.

Outcome Time Frame:

4 years

Safety Issue:

Yes

Principal Investigator

Edward A Neuwelt, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Knight Cancer Institute at Oregon Health & Science University

Authority:

United States: Food and Drug Administration

Study ID:

OHSU-4229

NCT ID:

NCT01138137

Start Date:

June 2010

Completion Date:

December 2015

Related Keywords:

  • Ovarian Carcinoma, Stage 3 or 4
  • Epithelial Ovarian Carcinoma
  • Primary Peritoneal Carcinoma
  • ovarian cancer
  • epithelial ovarian cancer
  • peritoneal cancer
  • Carcinoma
  • Ovarian Neoplasms
  • Neoplasms, Glandular and Epithelial

Name

Location

Oregon Health & Science UniversityPortland, Oregon  97201