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

NCT01659554 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: AAAI1246
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Recurrent Ovarian Cancer; Fallopian Tube Cancer

Keywords

Primary peritoneal

Outcome Measures

Primary Outcomes (2)

• Adverse Event Rate and/or Laboratory Changes

  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.

  5 years

• Toxicity Rating Based on NCI Common Toxicity Criteria

  Patients will be rated for toxicity prior to each cycle using the NCI Common Toxicity Criteria (NCICTC; see the CTCAE, Version 4.0).

  Up to 5 years

Secondary Outcomes (2)

• Time to Serum Ca-125 Nadir and/or CT Response (RECIST Criteria)

  Up to 5 years (survival)

• Kaplan-Meier Curves for Patient Overall Survival

  Up to 5 years, survival

Study Arms (1)

Out-Patient Intraperitoneal Chemotherapy

EXPERIMENTAL

Intraoperative (hyperthermic) cisplatin followed by 4 courses of intraperitoneal cisplatin and doxorubicin given on days 1 \& 8 during a 3 week cycle.

Drug: Cisplatin; Drug: Doxorubicin

Interventions

Cisplatin DRUG

Cisplatin (75 mg/m2) prepared in 2L normal saline.

Also known as: cis-diamminedichloroplatinum(II) (CDDP), Platinol, Platinol-AQ

Out-Patient Intraperitoneal Chemotherapy

Doxorubicin DRUG

Doxorubicin (25 mg flat dose) prepared in 500 ml dialysis fluid (glucose or icodextrin-based).

Also known as: hydroxyldaunorubicin, Adriamycin

Out-Patient Intraperitoneal Chemotherapy

Eligibility Criteria

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

You may qualify if:

• Patients must have histologically confirmed ovarian, primary peritoneal or fallopian tube carcinoma.
• Patients must have measurable evidence of recurrent intraabdominal disease based on Computed tomography (CT scan) findings.
• Patients must fulfill the following with regard to prior chemotherapy:
• weeks or greater since conclusion of prior chemotherapy;
• Prior intraperitoneal chemotherapy with cisplatin is acceptable; and,
• Prior systemic chemotherapy is acceptable.
• Patients must have a Karnofsky Performance Status of \> 70%
• Patients must have an estimated life expectancy of at least 16 weeks.
• Patient assurance of study compliance and geographic proximity that allows for adequate follow-up.
• 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
• Patient must have signed informed consent
• Patient must be at least 18 years of age
• Following cytoreductive surgery, patient's residual disease should be no larger than 1cm to Receive HIPEC and continue with normothermic IP chemotherapy

You may not qualify if:

• 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).
• 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.
• Prior radiation therapy within 4 weeks of enrollment.
• Have uncontrolled active systemic infection requiring therapy.
• Have a history of allergic reaction attributable to compounds containing boron or mannitol or hypersensitivity reactions to drugs formulated with polysorbate 80.
• Have had a serious concomitant systemic disorders (including oncologic emergencies) incompatible with the study (at the discretion of the investigator).
• 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.
• Have had any investigational agent within 4 weeks before enrollment into the study.
• 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.

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Ovarian Neoplasms; Fallopian Tube Neoplasms

Interventions

Cisplatin; Doxorubicin

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; 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; Fallopian Tube Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates

Limitations and Caveats

Zero participants analyzed due to early termination of study. Adverse Events could not be collected over the pre-specified Time Frame ("5 years") due to study termination

Results Point of Contact

• Title: Reena M. Vattakalam, CCRP
• Organization: Columbia University Medical Center

rmv2110@cumc.columbia.edu

212-342-6895

Study Officials

• Sharyn Lewin, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2012
• First Posted: August 8, 2012
• Study Start: March 1, 2012
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: March 10, 2017
• Results First Posted: March 3, 2015

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)