A Phase II Combined Modality Protocol of Debulking Surgery With HIPEC Followed by Intraperitoneal Chemotherapy for the Treatment of Recurrent Ovarian, Primary Peritoneal & Fallopian Tube Cancers

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by Columbia University
Sponsor:
Information provided by (Responsible Party):
Sharyn Lewin, MD, Columbia University
ClinicalTrials.gov Identifier:
NCT01659554
First received: July 10, 2012
Last updated: May 22, 2013
Last verified: May 2013
  Purpose

The primary objective of this study is to investigate the feasibility, tolerability and safety of surgical debulking and resection with heated intraoperative chemotherapy (HIPEC) followed by repeated intraperitoneal chemotherapy for treatment of recurrent ovarian, primary peritoneal, and fallopian tube carcinomas.


Condition Intervention Phase
Recurrent Ovarian Cancer,
Fallopian Tube Cancer
Drug: Intraoperative (hyperthermic) cisplatin followed by IP Cisplatin; Doxorubicin
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Combined Modality Protocol of Debulking Surgery With Heated Intraoperative Chemotherapy (HIPEC) Followed by Intraperitoneal Chemotherapy for the Treatment of Recurrent Ovarian, Primary Peritoneal and Fallopian Tube Cancers

Resource links provided by NLM:


Further study details as provided by Columbia University:

Primary Outcome Measures:
  • Adverse Event Rate and/or laboratory changes [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    The adverse event rate and laboratory changes will be used to investigate the safety of surgical debulking with heated intraperitoneal chemotherapy (HIPEC) combined with repeated intraperitoneal chemotherapy.

  • Toxicity Rating based on NCI Common Toxicity Criteria [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]
    Patients will be rated for toxicity prior to each cycle using the NCI Common Toxicity Criteria (NCICTC; see the CTCAE, Version 4.0).


Secondary Outcome Measures:
  • Time to Serum Ca-125 Nadir and/or CT Response (RECIST criteria) [ Time Frame: Up to 5 years (survival) ] [ Designated as safety issue: No ]
    Efficacy of surgical resection with HIPEC combined with repeated intraperitoneal chemotherapy: The end point will be the objective response rate and progression-free survival as well as the overall survival, if feasible. We will analyze the time to serum Ca 125 nadir and/or CT response based on Recist criteria.

  • Kaplan-Meier curves for patient overall survival [ Time Frame: Up to 5 years, survival ] [ Designated as safety issue: No ]
    Kaplan-Meier analysis will be done using PROC LIFETEST in Statistical Application Software (SAS).


Estimated Enrollment: 20
Study Start Date: March 2012
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intraoperative Cisplatin followed by IP Chemotherapy
Intraoperative (hyperthermic) cisplatin followed by 4 courses of intraperitoneal cisplatin and doxorubicin given on days 1 & 8 during a 3 week cycle
Drug: Intraoperative (hyperthermic) cisplatin followed by IP Cisplatin; Doxorubicin
Cisplatin 75 mg/m2 at 40.5-42.5 Celsius intraoperatively administered; IP Cisplatin 75 mg/m2 (Day 1) week 1 followed by IP Doxorubicin 25 mg week 2 (day 8) for four sequential 3 week cycles;

Detailed Description:

This is a phase II , open label, single center study of surgery followed by heated intraoperative cisplatin in patients with recurrent ovarian, primary peritoneal or fallopian tube cancers. Approximately twenty patients will receive surgery and intraoperative (hyperthermic) cisplatin followed by four consecutive courses of outpatient intraperitoneal cisplatin and doxorubicin given on days 1 and 8 during a 3 week cycle.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients must have histologically confirmed ovarian, primary peritoneal or fallopian tube carcinoma.
  2. Patients must have measurable evidence of recurrent intraabdominal disease based on Computed tomography (CT scan) findings.
  3. Patients must fulfill the following with regard to prior chemotherapy:

    1. 4 weeks or greater since conclusion of prior chemotherapy;
    2. Prior intraperitoneal chemotherapy with cisplatin is acceptable; and,
    3. Prior systemic chemotherapy is acceptable.
  4. Patients must have a Karnofsky Performance Status of > 70%
  5. Patients must have an estimated life expectancy of at least 16 weeks.
  6. Patient assurance of study compliance and geographic proximity that allows for adequate follow-up.
  7. Patients must have adequate organ function at the screening visit as defined by the following laboratory values:

Absolute neutrophil count (ANC) ≥1.5 x 109/L Platelet count ≥100 x 109/L Hemoglobin ≥8 g/dL Albumin ≥ 2 g/dL Total Bilirubin ≤ 2.5 x ULN* Alkaline phosphatase ≤ 3.0 x ULN* Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3.0 x ULN Creatinine ≤ 1.5 x ULN

[8] Patient must have signed informed consent

[9] Patient must be at least 18 years of age

[10] Following cytoreductive surgery, patient's residual disease should be no larger than 1cm to Receive HIPEC and continue with normothermic IP chemotherapy

-Exclusion criteria

  1. Have active peripheral neuropathy of Grade 2 or greater intensity, as defined by the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE; Version 4).
  2. Have experienced myocardial infarction within 6 months prior to enrollment or have New York Hospital Association (NYHA) Class III or IV heart failure (see section 16.4), uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
  3. Prior radiation therapy within 4 weeks of enrollment.
  4. Have uncontrolled active systemic infection requiring therapy.
  5. Have a history of allergic reaction attributable to compounds containing boron or mannitol or hypersensitivity reactions to drugs formulated with polysorbate 80.
  6. Have had a serious concomitant systemic disorders (including oncologic emergencies) incompatible with the study (at the discretion of the investigator).
  7. Have had a "currently active" second malignancy other than non-melanoma skin cancer or carcinoma in situ of the cervix are not to be registered. Patients who are not considered to have a "currently active" malignancy if they have completed therapy and are considered by their physician to be at less than 30% risk of relapse.
  8. Have had any investigational agent within 4 weeks before enrollment into the study.
  9. Have a history of a serious medical or psychiatric illness preventing informed consent or, in the opinion of the investigator, would make the patient a poor study candidate.
  10. Evidence of extraabdominal metastasis on preinclusion thoracic computed tomography (CT) scans (i.e. brain or chest disease).
  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: NCT01659554

Contacts
Contact: Reena Vattakalam 212-342-6895 rmv2110@columbia.edu

Locations
United States, New York
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Reena Vattakalam    212-342-6895    rmv2110@columbia.edu   
Contact: Sharyn N Lewin, MD    212-305-3410      
Principal Investigator: Sharyn Lewin, MD         
Sponsors and Collaborators
Columbia University
Investigators
Principal Investigator: Sharyn Lewin, MD Columbia University
  More Information

No publications provided

Responsible Party: Sharyn Lewin, MD, Assistant Clinical professor Division of Gynecologic Onoclogy, Columbia University
ClinicalTrials.gov Identifier: NCT01659554     History of Changes
Other Study ID Numbers: AAAI1246
Study First Received: July 10, 2012
Last Updated: May 22, 2013
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Columbia University:
Primary peritoneal

Additional relevant MeSH terms:
Ovarian Neoplasms
Fallopian Tube Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Fallopian Tube Diseases
Cisplatin
Doxorubicin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antibiotics, Antineoplastic

ClinicalTrials.gov processed this record on July 26, 2014