A Phase 2 interventional study of Cisplatin and Doxorubicin in Recurrent Ovarian Cancer and Fallopian Tube Cancer, sponsored by Columbia University. Terminated at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-03-10.
Sponsored by Columbia University · Phase 2, Interventional, and Treatment
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.
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.
2,757 studies on the registry are indexed under Ovarian Neoplasms; 735 are open to participants now.
This study's enrollment of 4 is below the median of 59 across 2,075 interventional studies indexed under Ovarian Neoplasms.
Browse Ovarian Neoplasms studies →Columbia University is the lead sponsor of 1,135 studies on the registry; 195 are open to participants now.
Of its 179 completed or terminated interventional studies of FDA-regulated products, 146 (82%) have results posted.
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Patients must fulfill the following with regard to prior chemotherapy:
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
Exclusion criteria:
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
Cisplatin (75 mg/m2) prepared in 2L normal saline.
Also known as: cis-diamminedichloroplatinum(II) (CDDP), Platinol, Platinol-AQ
Doxorubicin (25 mg flat dose) prepared in 500 ml dialysis fluid (glucose or icodextrin-based).
Also known as: hydroxyldaunorubicin, Adriamycin
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.
Time frame: 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).
Time frame: Up to 5 years
Time to Serum Ca-125 Nadir and/or CT Response (RECIST Criteria)
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.
Time frame: Up to 5 years (survival)
Kaplan-Meier Curves for Patient Overall Survival
Kaplan-Meier analysis will be done using PROC LIFETEST in Statistical Application Software (SAS).
Time frame: Up to 5 years, survival
Subjects were screened and enrolled during 10/23/2012 to 08/20/2013.
| Milestone | Intraoperative Cisplatin Followed by IP Chemotherapy |
|---|---|
| Started | 4 |
| Completed | 0 |
| Not completed | 4 |
| Withdrew: Study termination | 4 |
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.
No measurements were reported for this outcome.
Patients will be rated for toxicity prior to each cycle using the NCI Common Toxicity Criteria (NCICTC; see the CTCAE, Version 4.0).
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
Kaplan-Meier analysis will be done using PROC LIFETEST in Statistical Application Software (SAS).
No measurements were reported for this outcome.
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intraoperative Cisplatin Followed by IP Chemotherapy | — | 1/4 (25%) | 0/4 (0%) |
| Event | Intraoperative Cisplatin Followed by IP Chemotherapy |
|---|---|
| Ileus, Grade 3Gastrointestinal disorders | 1/4 |
| Grade 2 Abdominal PainInfections and infestations | 1/4 |
| IP drain infection, grade 3Infections and infestations | 1/4 |
| Nausea & vomitingGastrointestinal disorders | 1/4 |
| No Oliguric Acute Renal InjuryRenal and urinary disorders | 1/4 |
| Urinary Trasct Infection Grade 3Renal and urinary disorders | 1/4 |
| Right Shoulder cellulitisInfections and infestations | 1/4 |
| Fever with catheter related infectionInfections and infestations | 1/4 |
| Age, Categorical(Participants) | Intraoperative Cisplatin Followed by IP Chemotherapy |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 4 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | Intraoperative Cisplatin Followed by IP Chemotherapy |
|---|---|
| Female | 4 |
| Male | 0 |
| Region of Enrollment(participants) | Intraoperative Cisplatin Followed by IP Chemotherapy |
|---|---|
| United States | 4 |
Plan to share: No
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This study is terminated, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Cisplatin · Doxorubicin