Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Carcinoma, Uterine Cancer
Conditions
Keywords
Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Carcinoma, Uterine Cancer, Intraperitoneal Chemotherapy, IP Chemotherapy, Gynecologic Cancer, Women's Cancer, Cisplatin, Paclitaxel, Recurrent Platinum Sensitive Ovarian Cancer
Brief summary
The purpose of this study is to evaluate giving chemotherapy drugs directly into the abdomen (belly) along with intravenous administration.
Detailed description
Giving chemotherapy directly into the abdomen is called intraperitoneal (IP) chemotherapy. Because ovarian, fallopian, primary peritoneal and uterine cancer spread in the abdominal cavity, giving chemotherapy drugs by infusion into the abdominal cavity may result in a greater dose of the drugs reaching the tumor cells. Intraperitoneal treatments will be administered through an implantable peritoneal catheter. These catheters are to be inserted into the peritoneal cavity, tunneled through the subcutaneous tissue, and connected to an implantable port, which is placed in the subcutaneous tissue of the anterior, inferior thorax.
Interventions
DRUGPaclitaxel, Cisplatin IP
Paclitaxel 135 mg/m2 IV (3-hr infusion) on Day 1, Cisplatin 50 mg/m2 IP on Days 1 and 8, Repeat every 3 weeks for 6 cycles
Sponsors
University of Oklahoma
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Patients with stage IA, IB, IC, II, III, IV and recurrent platinum sensitive epithelial ovarian carcinoma, fallopian tube carcinoma, primary peritoneal carcinoma, or ovarian carcinosarcoma. Histologic subtypes which are eligible include serous adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, transitional cell carcinoma, malignant Brenner's tumor, adenocarcinoma (not otherwise specified), and carcinosarcoma. * Patients with advanced endometrial carcinoma, of any histology, including endometrioid adenocarcinoma, clear cell adenocarcinoma, and serous papillary carcinoma. * Patients with uterine carcinosarcoma of any stage are eligible.
Exclusion criteria
* Patients with epithelial ovarian carcinoma of low malignant potential (borderline carcinomas). * Patients with septicemia, severe infection, or acute hepatitis. * Patients with prior malignancy or cancer treatment within the last five years.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Patients Who Are Able to Receive 6 Cycles of Intraperitoneal Cisplatin Chemotherapy. | 3 years |
Secondary
| Measure | Time frame |
|---|---|
| Number of Patients With Dose Reductions or Dose Delays Due to Neuropathy or Toxicity | 3 years |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Paclitaxel, Cisplatin IP There is only one arm for this study and it represents the participants receiving the intraperitoneal chemotherapy
Paclitaxel, Cisplatin IP: Paclitaxel 135 mg/m2 IV (3-hr infusion) on Day 1, Cisplatin 50 mg/m2 IP on Days 1 and 8, Repeat every 3 weeks for 6 cycles | 21 |
| Total | 21 |
Baseline characteristics
| Characteristic | Paclitaxel, Cisplatin IP |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 4 Participants |
| Age, Categorical Between 18 and 65 years | 17 Participants |
| Age, Continuous | 61 years |
| Region of Enrollment United States | 21 Participants |
| Sex: Female, Male Female | 21 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 21 |
| other Total, other adverse events | 6 / 21 |
| serious Total, serious adverse events | 1 / 21 |
Outcome results
Primary
Number of Patients Who Are Able to Receive 6 Cycles of Intraperitoneal Cisplatin Chemotherapy.
Time frame: 3 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Paclitaxel, Cisplatin IP | Number of Patients Who Are Able to Receive 6 Cycles of Intraperitoneal Cisplatin Chemotherapy. | 7 Participants |
Secondary
Number of Patients With Dose Reductions or Dose Delays Due to Neuropathy or Toxicity
Time frame: 3 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Paclitaxel, Cisplatin IP | Number of Patients With Dose Reductions or Dose Delays Due to Neuropathy or Toxicity | 7 Participants |