Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Hyperthermic Intraperitoneal Chemotherapy or Intraperitoneal Chemotherapy in Comparing Quality of Life in Patients With Stage IIIC-IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03188432
Recruitment Status : Recruiting
First Posted : June 15, 2017
Last Update Posted : September 6, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Brief Summary:
This randomized phase II trial studies hyperthermic intraperitoneal chemotherapy or intraperitoneal chemotherapy in improving quality of life in patients with stage IIIC-IV ovarian, fallopian tube, or primary peritoneal cancer. In hyperthermic intraperitoneal chemotherapy, the chemotherapy is warmed before being used and may help the drugs get into the cancer cells better, minimize the toxicity of the drugs on normal cells, and help to kill any cancer cells left over after surgery. Intraperitoneal chemotherapy is delivered directly to the abdominal cavity to help treat cancer. It is not yet known whether hyperthermic intraperitoneal chemotherapy or intraperitoneal chemotherapy works better in improving quality of life in patients with ovarian, fallopian tube, or primary peritoneal cancer.

Condition or disease Intervention/treatment Phase
Stage IIIC Fallopian Tube Cancer Stage IIIC Ovarian Cancer Stage IIIC Primary Peritoneal Cancer Stage IV Fallopian Tube Cancer Stage IV Ovarian Cancer Stage IV Primary Peritoneal Cancer Drug: Carboplatin Drug: Paclitaxel Other: Quality-of-Life Assessment Other: Questionnaire Administration Procedure: Surgical Procedure Phase 2

Detailed Description:

PRIMARY OBJECTIVES:

I. To compare quality of life in patients with advanced ovarian cancer treated with neoadjuvant chemotherapy (NAC) followed by cytoreductive surgery (CRS) with hyperthermic intraperitoneal chemotherapy (HIPEC) versus NAC followed by CRS and postoperative intraperitoneal (IP) chemotherapy at 6 weeks post-treatment.

SECONDARY OBJECTIVES:

I. To compare quality of life in patients with advanced ovarian cancer treated with NAC followed by CRS with HIPEC versus NAC followed by CRS and postoperative IP chemotherapy at 3 and 6 months post-treatment.

II. To compare neurotoxicity in patients with advanced ovarian cancer treated with NAC followed by CRS with HIPEC versus NAC followed by CRS and postoperative IP chemotherapy III. To compare abdominal discomfort in patients with advanced ovarian cancer treated with NAC followed by CRS with HIPEC versus NAC followed by CRS and postoperative IP chemotherapy IV. To compare toxicities in patients with advanced ovarian cancer treated with NAC followed by CRS with HIPEC versus NAC followed by CRS and postoperative IP chemotherapy.

V. To compare the response rate in patients with advanced ovarian cancer treated with NAC followed by CRS with HIPEC versus NAC followed by CRS and postoperative IP chemotherapy.

VI. To compare progression free survival (PFS) in patients with advanced ovarian cancer treated with NAC followed by CRS with HIPEC versus NAC followed by CRS and postoperative IP chemotherapy.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive paclitaxel intravenously (IV) over 60 minutes on days 1, 8, and 15 and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Beginning 4-8 weeks after 3 courses of chemotherapy, patients undergo CRS. Beginning 4-8 weeks after CRS, patients receive paclitaxel IV over 60 minutes on days 1, 8, and 15 and carboplatin intraperitoneally (IP) over 30-60 minutes on day 1. Treatment repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive paclitaxel IV over 90 minutes on days 1, 8, and 15 and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Beginning 4-8 weeks after 6 courses of chemotherapy, patients undergo CRS. Patients then receive carboplatin IP over 120 minutes immediately following CRS.

After completion of chemotherapy, patients are followed up at 6 weeks, and 3, 6, and 12 months.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial Comparing Quality of Life After HIPEC Versus IP Chemotherapy in Patients With Stage IIIC and IV Ovarian, Fallopian Tube or Primary Peritoneal Carcinoma
Actual Study Start Date : October 13, 2017
Estimated Primary Completion Date : November 1, 2019
Estimated Study Completion Date : July 1, 2020


Arm Intervention/treatment
Experimental: Arm I (paclitaxel, carboplatin, CRS, IP chemotherapy)
Patients receive paclitaxel IV over 60 minutes on days 1, 8, and 15 and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Beginning 4-8 weeks after 3 courses of chemotherapy, patients undergo CRS. Beginning 4-8 weeks after CRS, patients receive paclitaxel IV over 60 minutes on days 1, 8, and 15 and carboplatin IP over 30-60 minutes on day 1. Treatment repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.
Drug: Carboplatin
Given IV and IP
Other Names:
  • Blastocarb
  • Carboplat
  • Carboplatin Hexal
  • Carboplatino
  • Carbosin
  • Carbosol
  • Carbotec
  • CBDCA
  • Displata
  • Ercar
  • JM-8
  • Nealorin
  • Novoplatinum
  • Paraplatin
  • Paraplatin AQ
  • Paraplatine
  • Platinwas
  • Ribocarbo

Drug: Paclitaxel
Given IV
Other Names:
  • Anzatax
  • Asotax
  • Bristaxol
  • Praxel
  • Taxol
  • Taxol Konzentrat

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies

Procedure: Surgical Procedure
Undergo CRS
Other Names:
  • Operation
  • Surgery
  • Surgical
  • Surgical Interventions
  • Surgical Procedures

Experimental: Arm II (paclitaxel, carboplatin, CRS, HIPEC)
Patients receive paclitaxel IV over 90 minutes on days 1, 8, and 15 and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Beginning 4-8 weeks after 6 courses of chemotherapy, patients undergo CRS. Patients then receive carboplatin IP over 120 minutes immediately following CRS.
Drug: Carboplatin
Given IV and IP
Other Names:
  • Blastocarb
  • Carboplat
  • Carboplatin Hexal
  • Carboplatino
  • Carbosin
  • Carbosol
  • Carbotec
  • CBDCA
  • Displata
  • Ercar
  • JM-8
  • Nealorin
  • Novoplatinum
  • Paraplatin
  • Paraplatin AQ
  • Paraplatine
  • Platinwas
  • Ribocarbo

Drug: Paclitaxel
Given IV
Other Names:
  • Anzatax
  • Asotax
  • Bristaxol
  • Praxel
  • Taxol
  • Taxol Konzentrat

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies

Procedure: Surgical Procedure
Undergo CRS
Other Names:
  • Operation
  • Surgery
  • Surgical
  • Surgical Interventions
  • Surgical Procedures




Primary Outcome Measures :
  1. Quality of life (QOL) assessed using Functional Assessment of Cancer Therapy-Ovarian questionnaire [ Time Frame: At 6 weeks ]
    The longitudinal data of QOL will be displayed graphically with individual trajectories. Repeated measures analysis of covariance models will be used for the primary analysis. The baseline QOL visit (as a categorical variable), randomization assignment, and a randomization by visit interaction will be included in the model. The test for the randomization effect at the 6-week post-treatment will be performed using a contrast of the 6-week randomization means. An unstructured covariance matrix will be used.


Secondary Outcome Measures :
  1. Abdominal discomfort assessed using Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Abdominal Discomfort questionnaire [ Time Frame: Up to 6 months ]
    Abdominal discomfort will be compared between the two treatment arms. The data will be analyzed using Poisson model with GEEs to account for the dependency between repeated measures. This approach will be treated as a sensitivity analysis.

  2. Incidence of toxicities evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 [ Time Frame: Up to 1 year after surgery ]
    Toxicities will be compared between the two treatment arms. The toxicities will be measured by the number and severity of adverse events defined by CTCAE version 4.0. The count data will be compared assuming a Poisson distribution.

  3. Neurotoxicity assessed using Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity questionnaire [ Time Frame: Up to 6 months ]
    Neurotoxicity will be compared between the two treatment arms. The data will be analyzed using Poisson model with generalized estimating equations (GEEs) to account for the dependency between repeated measures. This approach will be treated as a sensitivity analysis.

  4. Progression free survival [ Time Frame: Up to 3 years ]
    Progression free survival will be compared between the two treatment arms using survival analysis. The follow-up time will be calculated from the date of end of treatment. Survival will be measured up to the time until progression, date of last contact, or death, whichever comes first. Kaplan-Meier survival curves will be used to estimate the survival probabilities by treatment arms. Cox proportional hazards models will be used to calculate the hazards ratio and its confidence interval for the treatment effect.

  5. Quality of life (QOL) assessed using Functional Assessment of Cancer Therapy-Ovarian [ Time Frame: At 3 months ]
    The test for the randomization effect will be performed using contrasts.

  6. Quality of life (QOL) in patients with advanced ovarian cancer assessed using Functional Assessment of Cancer Therapy-Ovarian [ Time Frame: At 6 months ]
    The test for the randomization effect will be performed using contrasts.

  7. Response rates evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 [ Time Frame: Up to 1 year post surgery ]
    The best response using RECIST criteria will be compared between the two treatment arms over time using GEEs to account for the dependency between repeated measures. Logit link and binomial distribution will be applied. The randomization assignment, visit (as a categorical variable), and interaction between randomization and visit will be included in the model. Contrasts will be used to compare the best response at each time point.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must have histologically or cytologically confirmed non-mucinous, epithelial stage 3 or 4 carcinoma of the ovary, fallopian tube or peritoneum
  • Patients must not have received treatment for another malignancy within 3 years of enrollment
  • Patients must have received at least 3 but not more than 6 cycles of platinum-taxane based IV neoadjuvant chemotherapy and achieved at least stable disease (RECIST criteria) at the conclusion of this therapy.
  • Eastern Cooperative Oncology Group (ECOG) performance status =< 2
  • Patients must have adequate organ and marrow function as defined below (within 30 days of registration):
  • Absolute neutrophil count >= 1,500/mcL
  • Platelets >= 75,000/mcL
  • Total bilirubin =< 1.5 mg/dL
  • Creatinine clearance >= 50 mg/dL
  • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) =< 3 x institutional upper limit of normal
  • Alkaline phosphatase =< 3 x institutional upper limit of normal
  • Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
  • Ability to understand and the willingness to sign an institutional review board (IRB)-approved informed consent document (either directly or via a legally authorized representative)

Exclusion Criteria:

  • Patients may not be receiving any other investigational agents
  • Patients with extra-abdominal metastatic disease
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to paclitaxel or carboplatin
  • Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Pregnant women are excluded from this study; breastfeeding should be discontinued.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03188432


Locations
Layout table for location information
United States, North Carolina
Wake Forest University Health Sciences Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Michael G. Kelly    336-716-4389    mgkelly@wakehealth.edu   
Principal Investigator: Michael G. Kelly         
Sponsors and Collaborators
Wake Forest University Health Sciences
National Cancer Institute (NCI)
Investigators
Layout table for investigator information
Principal Investigator: Michael Kelly Wake Forest University Health Sciences

Layout table for additonal information
Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT03188432     History of Changes
Other Study ID Numbers: IRB00044434
NCI-2017-01045 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CCCWFU 83216 ( Other Identifier: Wake Forest University Health Sciences )
P30CA012197 ( U.S. NIH Grant/Contract )
First Posted: June 15, 2017    Key Record Dates
Last Update Posted: September 6, 2019
Last Verified: September 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Fallopian Tube Neoplasms
Peritoneal 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
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Fallopian Tube Diseases
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Carboplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators