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
Conditions
Brief summary
This phase II trial studies how well hyperthermic intraperitoneal chemotherapy works 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.
Detailed description
PRIMARY OBJECTIVES: I. To describe quality of life in patients with advanced ovarian cancer treated with standard of care (SOC) neoadjuvant chemotherapy (NAC) followed by cytoreductive surgery (CRS) with hyperthermic intraperitoneal chemotherapy (HIPEC) at 6 weeks post-treatment. SECONDARY OBJECTIVES: I. To describe quality of life in patients with advanced ovarian cancer treated with NAC followed by CRS with HIPEC at 3 and 6 months post-treatment. II. To describe neurotoxicity in patients with advanced ovarian cancer treated with NAC followed by CRS with HIPEC. III. To describe abdominal discomfort in patients with advanced ovarian cancer treated with NAC followed by CRS with HIPEC. IV. To describe toxicities in patients with advanced ovarian cancer treated with NAC followed by CRS with HIPEC. V. To describe the response rate in patients with advanced ovarian cancer treated with NAC followed by CRS with HIPEC. VI. To describe progression-free survival (PFS) in patients with advanced ovarian cancer treated with NAC followed by CRS with HIPEC. OUTLINE: Beginning 4-8 weeks after completion of chemotherapy, patients undergo CRS. Patients then receive carboplatin intraperitoneally (IP) over 90 minutes immediately following CRS. After completion of chemotherapy, patients are followed up at 30 days, and 3, 6, and 12 months.
Interventions
DRUGCarboplatin
Given IV and IP
OTHERQuality-of-Life Assessment
Ancillary studies
OTHERQuestionnaire Administration
Ancillary studies
PROCEDURECytoreductive Surgery
Undergo CRS
Sponsors
Wake Forest University Health Sciences
National Cancer Institute (NCI)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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 who have received hormone therapy within 3 years of enrollment are still eligible). * Patients must have received at least 3 but not more than 6 cycles of carboplatin-doublet based IV neoadjuvant chemotherapy and achieved at least stable disease (radiographically confirmed) at the conclusion of this therapy. * Age ≥ 18 years. * 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 (within 30 days of registration) * Platelets \>= 75,000/mcL (within 30 days of registration) * Total bilirubin =\< 1.5 mg/dL (within 30 days of registration) * Creatinine clearance \>= 50 mg/dL (within 30 days of registration) * Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \[SGPT\]) =\< 3 x institutional upper limit of normal (within 30 days of registration) * Alkaline phosphatase =\< 3 x institutional upper limit of normal (within 30 days of registration) * The effects of HIPEC on the developing human fetus are unknown. For this reason, and because carboplatin doublet therapy consists of pregnancy category D agents, women of child-bearing potential 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.
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 carboplatin doublet agents. * 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 because carboplatin doublet therapy consists of pregnancy category D agents with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with carboplatin doublet therapy, breastfeeding should be discontinued. * Men are excluded from participating due to the site specific nature of the disease being studied.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life (QOL) Assessed Using Functional Assessment of Cancer Therapy-Ovarian Questionnaire (FACT-O) | At 6 weeks post treatment | This is a descriptive study. QOL will be measured using the Fact-O questionnaire and treated as a continuous outcome. The distribution of QOL at 6 weeks post-treatment will be examined. Descriptive statistics such as mean, standard deviation, median and interquartile range will be calculated. The FACT-O consists of 39 questions answered with five-point Likert Scales (0-4). The possible range of scores is 0-156, and higher scores indicate a better quality of life. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Abdominal Discomfort Assessed Using Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Abdominal Discomfort Questionnaire | Pre-treatment (baseline), 3 months after surgery, 6 months after surgery | To describe abdominal discomfort at up to 3 times points during the study, descriptive statistics will be calculated and presented based on a 4-item score from FACT-GOG/AD. Counts and percentages will be calculated. Mean and standard deviation also will be calculated. This approach will be treated as a sensitivity analysis. The Abdominal Discomfort section of the FACT-O uses 4 questions with five-point Likert Scales (0-4). The possible range of scores is 0-16, and higher scores indicate a better quality of life (less discomfort), |
| Number of Toxicities Reported (National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0) | Up to 6 weeks post treatment | The toxicities will be measured by the number and severity of adverse events defined by CTCAE version 5.0. Counts and percentages will be calculated for each type of adverse event. The counts were grouped in the table below. A particular count might include several occurrences of the same event (eg, anemia) or one occurrence of several different events. |
| Neurotoxicity Assessed Using Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity Questionnaire | Up to 6 months | Neurotoxicity at up to three time points in the study will be described. The neurotoxicity subscale is an 11-item measure from FACT/GOG-NTX. The possible range of scores is 0 to 44, with higher scores indicating lower quality of life (more neurotoxicity). |
| Progression Free Survival | Up to 2 years from study enrollment | Progression free survival will be estimated using Kaplan-Meier methods, using the time from the study registration up to date of progression, date of last contact, or death, whichever comes first. |
| Quality of Life (QOL) Assessed Using Functional Assessment of Cancer Therapy-Ovarian (FACT-O) | At 3 months post treatment | The distribution of QOL based on the Fact-O questionnaire at 3 months post-treatment will be examined. The descriptive statistics of QOL at 3 months post-treatment will be presented. The FACT-O consists of 39 questions answered with five-point Likert Scales (0-4). The possible range of scores is 0-156, and higher scores indicate a better quality of life. |
| Quality of Life (QOL) in Patients With Advanced Ovarian Cancer Assessed Using Functional Assessment of Cancer Therapy-Ovarian (FACT-O) | At 6 months post treatment | The distribution of QOL based on the Fact-O questionnaire at 6 months post-treatment will be examined. The descriptive statistics of QOL at 6 months post-treatment will be presented. The FACT-O consists of 39 questions answered with five-point Likert Scales (0-4). The possible range of scores is 0-156, and higher scores indicate a better quality of life. |
| Response Rates Evaluated According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 | Up to 6 weeks post surgery | The best overall response using RECIST criteria will be determined for each evaluable patient and proportions achieving a complete or partial response will be estimated with 95% confidence intervals. Complete response means all target lesions have disappeared; partial response requires at least a 30% decrease in the sum of the longest diameters of target lesions from baseline. Progressive disease is defined by a 20% increase in the sum of the longest diameters of target lesions or the appearance of new lesions. Stable disease is defined as the absence of sufficient changes to qualify for partial response or progressive disease. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMichael Kelly
Wake Forest University Health Sciences
Participant flow
Recruitment details
Enrollment period was January 2019 through December 2023.
Participants by arm
| Arm | Count |
|---|---|
| Treatment - Carboplatin, CRS, HIPEC Beginning 4-8 weeks after completion of chemotherapy, patients undergo CRS. Patients then receive carboplatin IP over 90 minutes immediately following CRS.
Carboplatin: Given IV and IP
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Cytoreductive Surgery: Undergo CRS | 50 |
| Total | 50 |
Baseline characteristics
| Characteristic | Treatment - Carboplatin, CRS, HIPEC |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 25 Participants |
| Age, Categorical Between 18 and 65 years | 25 Participants |
| Age, Continuous | 64.7 years STANDARD_DEVIATION 9.1 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 48 Participants |
| Region of Enrollment United States | 50 participants |
| Sex: Female, Male Female | 50 Participants |
| Sex: Female, Male Male | 0 Participants |
| Tumor Location Ovary | 33 Participants |
| Tumor Location Peritoneum | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 6 / 50 |
| other Total, other adverse events | 41 / 41 |
| serious Total, serious adverse events | 27 / 41 |
Outcome results
Primary
Quality of Life (QOL) Assessed Using Functional Assessment of Cancer Therapy-Ovarian Questionnaire (FACT-O)
This is a descriptive study. QOL will be measured using the Fact-O questionnaire and treated as a continuous outcome. The distribution of QOL at 6 weeks post-treatment will be examined. Descriptive statistics such as mean, standard deviation, median and interquartile range will be calculated. The FACT-O consists of 39 questions answered with five-point Likert Scales (0-4). The possible range of scores is 0-156, and higher scores indicate a better quality of life.
Time frame: At 6 weeks post treatment
Population: All participants did not have data collected for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment - Carboplatin, CRS, HIPEC | Quality of Life (QOL) Assessed Using Functional Assessment of Cancer Therapy-Ovarian Questionnaire (FACT-O) | 116.32 score on a scale | Standard Deviation 25.37 |
Secondary
Abdominal Discomfort Assessed Using Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Abdominal Discomfort Questionnaire
To describe abdominal discomfort at up to 3 times points during the study, descriptive statistics will be calculated and presented based on a 4-item score from FACT-GOG/AD. Counts and percentages will be calculated. Mean and standard deviation also will be calculated. This approach will be treated as a sensitivity analysis. The Abdominal Discomfort section of the FACT-O uses 4 questions with five-point Likert Scales (0-4). The possible range of scores is 0-16, and higher scores indicate a better quality of life (less discomfort),
Time frame: Pre-treatment (baseline), 3 months after surgery, 6 months after surgery
Population: The most patients completed the survey at 6 months after surgery; most of them also completed the survey at baseline, and the fewest completed the survey at 3 months after surgery.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment - Carboplatin, CRS, HIPEC | Abdominal Discomfort Assessed Using Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Abdominal Discomfort Questionnaire | Pre-treatment | 1.76 score on a scale | Standard Deviation 2.7 |
| Treatment - Carboplatin, CRS, HIPEC | Abdominal Discomfort Assessed Using Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Abdominal Discomfort Questionnaire | 3 months after surgery | 1.79 score on a scale | Standard Deviation 2.4 |
| Treatment - Carboplatin, CRS, HIPEC | Abdominal Discomfort Assessed Using Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Abdominal Discomfort Questionnaire | 6 months after surgery | 3.13 score on a scale | Standard Deviation 4.4 |
Secondary
Neurotoxicity Assessed Using Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity Questionnaire
Neurotoxicity at up to three time points in the study will be described. The neurotoxicity subscale is an 11-item measure from FACT/GOG-NTX. The possible range of scores is 0 to 44, with higher scores indicating lower quality of life (more neurotoxicity).
Time frame: Up to 6 months
Population: 47 patients completed this survey at baseline, 27 at 6 weeks post-surgery, 22 at 3 months post-surgery and 19 at 6 months post-surgery.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment - Carboplatin, CRS, HIPEC | Neurotoxicity Assessed Using Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity Questionnaire | Baseline | 33.92 score on a scale | Standard Deviation 8.7 |
| Treatment - Carboplatin, CRS, HIPEC | Neurotoxicity Assessed Using Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity Questionnaire | 6 weeks post surgery | 33.51 score on a scale | Standard Deviation 9.25 |
| Treatment - Carboplatin, CRS, HIPEC | Neurotoxicity Assessed Using Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity Questionnaire | 3 months post surgery | 35.59 score on a scale | Standard Deviation 8.61 |
| Treatment - Carboplatin, CRS, HIPEC | Neurotoxicity Assessed Using Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity Questionnaire | 6 months post surgery | 33.38 score on a scale | Standard Deviation 10.01 |
Secondary
Number of Toxicities Reported (National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0)
The toxicities will be measured by the number and severity of adverse events defined by CTCAE version 5.0. Counts and percentages will be calculated for each type of adverse event. The counts were grouped in the table below. A particular count might include several occurrences of the same event (eg, anemia) or one occurrence of several different events.
Time frame: Up to 6 weeks post treatment
Population: All participants able to receive the full protocol treatment.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Treatment - Carboplatin, CRS, HIPEC | Number of Toxicities Reported (National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0) | Non-Serious Adverse Events | Zero Adverse Events | 0 Participants |
| Treatment - Carboplatin, CRS, HIPEC | Number of Toxicities Reported (National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0) | Non-Serious Adverse Events | One to Four Adverse Events | 2 Participants |
| Treatment - Carboplatin, CRS, HIPEC | Number of Toxicities Reported (National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0) | Non-Serious Adverse Events | Five to Nine Adverse Events | 6 Participants |
| Treatment - Carboplatin, CRS, HIPEC | Number of Toxicities Reported (National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0) | Non-Serious Adverse Events | Ten to Fourteen Adverse Events | 13 Participants |
| Treatment - Carboplatin, CRS, HIPEC | Number of Toxicities Reported (National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0) | Non-Serious Adverse Events | Fifteen to Nineteen Adverse Events | 11 Participants |
| Treatment - Carboplatin, CRS, HIPEC | Number of Toxicities Reported (National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0) | Non-Serious Adverse Events | Twenty or More Adverse Events | 9 Participants |
| Treatment - Carboplatin, CRS, HIPEC | Number of Toxicities Reported (National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0) | Serious Adverse Events | Zero Adverse Events | 32 Participants |
| Treatment - Carboplatin, CRS, HIPEC | Number of Toxicities Reported (National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0) | Serious Adverse Events | One to Four Adverse Events | 6 Participants |
| Treatment - Carboplatin, CRS, HIPEC | Number of Toxicities Reported (National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0) | Serious Adverse Events | Five to Nine Adverse Events | 2 Participants |
| Treatment - Carboplatin, CRS, HIPEC | Number of Toxicities Reported (National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0) | Serious Adverse Events | Ten to Fourteen Adverse Events | 1 Participants |
| Treatment - Carboplatin, CRS, HIPEC | Number of Toxicities Reported (National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0) | Serious Adverse Events | Fifteen to Nineteen Adverse Events | 0 Participants |
| Treatment - Carboplatin, CRS, HIPEC | Number of Toxicities Reported (National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0) | Serious Adverse Events | Twenty or More Adverse Events | 0 Participants |
Secondary
Progression Free Survival
Progression free survival will be estimated using Kaplan-Meier methods, using the time from the study registration up to date of progression, date of last contact, or death, whichever comes first.
Time frame: Up to 2 years from study enrollment
Population: All enrolled participants
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Treatment - Carboplatin, CRS, HIPEC | Progression Free Survival | 12.46 months |
Secondary
Quality of Life (QOL) Assessed Using Functional Assessment of Cancer Therapy-Ovarian (FACT-O)
The distribution of QOL based on the Fact-O questionnaire at 3 months post-treatment will be examined. The descriptive statistics of QOL at 3 months post-treatment will be presented. The FACT-O consists of 39 questions answered with five-point Likert Scales (0-4). The possible range of scores is 0-156, and higher scores indicate a better quality of life.
Time frame: At 3 months post treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment - Carboplatin, CRS, HIPEC | Quality of Life (QOL) Assessed Using Functional Assessment of Cancer Therapy-Ovarian (FACT-O) | 126.11 score on a scale | Standard Deviation 20.25 |
Secondary
Quality of Life (QOL) in Patients With Advanced Ovarian Cancer Assessed Using Functional Assessment of Cancer Therapy-Ovarian (FACT-O)
The distribution of QOL based on the Fact-O questionnaire at 6 months post-treatment will be examined. The descriptive statistics of QOL at 6 months post-treatment will be presented. The FACT-O consists of 39 questions answered with five-point Likert Scales (0-4). The possible range of scores is 0-156, and higher scores indicate a better quality of life.
Time frame: At 6 months post treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment - Carboplatin, CRS, HIPEC | Quality of Life (QOL) in Patients With Advanced Ovarian Cancer Assessed Using Functional Assessment of Cancer Therapy-Ovarian (FACT-O) | 119.53 score on a scale | Standard Deviation 31.4 |
Secondary
Response Rates Evaluated According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
The best overall response using RECIST criteria will be determined for each evaluable patient and proportions achieving a complete or partial response will be estimated with 95% confidence intervals. Complete response means all target lesions have disappeared; partial response requires at least a 30% decrease in the sum of the longest diameters of target lesions from baseline. Progressive disease is defined by a 20% increase in the sum of the longest diameters of target lesions or the appearance of new lesions. Stable disease is defined as the absence of sufficient changes to qualify for partial response or progressive disease.
Time frame: Up to 6 weeks post surgery
Population: All participants who were able to complete all treatment according to protocol.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment - Carboplatin, CRS, HIPEC | Response Rates Evaluated According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 | Complete Reponse | 17 Participants |
| Treatment - Carboplatin, CRS, HIPEC | Response Rates Evaluated According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 | Partial Response | 17 Participants |
| Treatment - Carboplatin, CRS, HIPEC | Response Rates Evaluated According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 | Stable Disease | 3 Participants |
| Treatment - Carboplatin, CRS, HIPEC | Response Rates Evaluated According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 | Progressive Disease | 4 Participants |