View Clinical Trial (Medical Research Study)
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
| City: |
|
Portland |
| State: |
|
Oregon |
| Zip Code: |
|
97239 |
| Conditions: |
|
Ovarian Carcinoma, Stage 3 or 4 - Epithelial Ovarian Carcinoma - Primary Peritoneal Carcinoma |
| Purpose: |
|
RATIONAL FOR STUDYING IV NAC AS POTENTIAL CHEMOPROTECTANT:
Cisplatin has shown efficacy in the treatment of subjects with epithelial ovarian cancer.
Systemic toxicities associated with cisplatin include nephro, oto, and nerve toxicities. It
may be possible to reduce the toxicities of cisplatin by administering it in conjunction
with IV NAC. NAC may reduce cisplatin related nephro, oto, and nerve toxicities without
compromising the effectiveness of the chemotherapy against the ovarian cancer cells. It is
possible that this combination of drugs may in the future allow ovarian cancer patients to
receive the full series of IP cisplatin-paclitaxel chemotherapy, with fewer side effects and
improved survival.
It is hypothesized that the proposed treatment of stage III or IV epithelial ovarian cancer
with IP cisplatin and IV/IP paclitaxel in conjunction with IV NAC will limit the
neurotoxicity, nephrotoxicity and ototoxicity that is associated with cisplatin
administration.
|
| Study Summary: |
|
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.
|
| Criteria: |
|
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.
|
| NCT ID: |
|
NCT01138137 |
| Primary Contact: |
|
Principal Investigator
Edward A Neuwelt, MD
Knight Cancer Institute at Oregon Health & Science University
Edward A Neuwelt, MD
Phone: 503-494-5626
Email: neuwelte@ohsu.edu
|
| Backup Contact: |
|
Email: hedrickn@ohsu.edu
Nancy A Hedrick, BA
Phone: 503-494-5626
|
| Location Contact: |
|
Portland, Oregon 97239
United States
Edward A Neuwelt, MD
Phone: 503-494-5626
Email: neuwelte@ohsu.edu
Site Status: Recruiting |
| Data Source: |
|
ClinicalTrials.gov |
| Date Processed: |
|
May 22, 2013 |
| Modifications to this listing: |
|
Only selected fields are shown, please use the link
below to view all information about this clinical trial. |
|
Click to view Full Listing
|