Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00814086
Other study ID # GOG-9921
Secondary ID NCI-2009-00624GO
Status Completed
Phase Phase 1
First received December 20, 2008
Last updated December 29, 2014
Start date February 2009

Study information

Verified date December 2014
Source Gynecologic Oncology Group
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

This phase I trial is studying the side effects and best dose of cisplatin given together with paclitaxel in treating patients with stage IIB, stage IIC, stage III, or stage IV ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cavity cancer. Drugs used in chemotherapy, such as cisplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) and giving them in different ways may kill more tumor cells.


Description:

Read more »
Read more »

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms

Read more »

Intervention

Drug:
Paclitaxel
Given IV or intraperitoneally
Cisplatin
Given intraperitoneally

Locations

Country Name City State
United States Cooper Hospital University Medical Center Camden New Jersey
United States University of Chicago Comprehensive Cancer Center Chicago Illinois
United States Riverside Methodist Hospital Columbus Ohio
United States University of Iowa Hospitals and Clinics Iowa City Iowa
United States University of Wisconsin Hospital and Clinics Madison Wisconsin
United States Women and Infants Hospital Providence Rhode Island
United States Tulsa Cancer Institute Tulsa Oklahoma

Sponsors (2)

Lead Sponsor Collaborator
Gynecologic Oncology Group National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of patients who have at least 1 dose-limiting toxicity or delay in therapy for more than 2 weeks 12 weeks Yes
Secondary Grade of toxicity as assessed by Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0) Up to 1 year Yes
Secondary Adverse events related to the catheter or the surgical placement of the catheter Up to 1 year Yes
Secondary Objective tumor response (partial or complete) assessed by Response Evaluation Criteria for Solid Tumors (RECIST) Up to 1 year No
See also
  Status Clinical Trial Phase
Completed NCT01442051 - Acute Normovolemic Hemodilution in Patients Undergoing Cytoreductive Surgery for Advanced Ovarian Cancer N/A
Active, not recruiting NCT03648489 - Dual mTorc Inhibition in advanCed/Recurrent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer (of Clear Cell, Endometrioid and High Grade Serous Type, and Carcinosarcoma) Phase 2
Completed NCT01031381 - Study of RAD001 and Bevacizumab in Recurrent Ovarian, Peritoneal, and Fallopian Tube Cancer Phase 2
Terminated NCT01202890 - Study of Revlimid With Doxil and Avastin for Patients With Platinum Resistant Ovarian Cancer Phase 1
Completed NCT00561795 - Feasibility Study of Pazopanib in Combination With Chemotherapy in Gynaecological Tumors Phase 2
Completed NCT00301756 - Belinostat in Treating Patients With Advanced Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer or Ovarian Low Malignant Potential Tumors Phase 2
Completed NCT00066456 - Radiation Therapy to the Abdomen Plus Docetaxel in Treating Patients With Recurrent or Persistent Advanced Ovarian, Peritoneal, or Fallopian Tube Cancer Phase 1
Completed NCT00045682 - CT-2103 in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer or Primary Peritoneal Cancer Phase 2
Withdrawn NCT04368130 - SIGNAL:Identifying Behavioral Anomalies Using Smartphones to Improve Cancer Care N/A
Terminated NCT04814875 - A Study to Evaluate the Combination of ATX-101 and Platinum-based Chemotherapy Phase 1/Phase 2
Completed NCT00989651 - Carboplatin, Paclitaxel, Bevacizumab, and Veliparib in Treating Patients With Newly Diagnosed Stage II-IV Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer Phase 1
Recruiting NCT05537844 - Longitudinal Sample Collection to Investigate Adaptation and Evolution of Ovarian High-grade Serous Carcinoma
Terminated NCT03585764 - MOv19-BBz CAR T Cells in aFR Expressing Recurrent High Grade Serous Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Phase 1
Completed NCT04088786 - Phase I Trial HIPEC With Nal-irinotecan Phase 1
Completed NCT03921658 - The Role of Cytomegalovirus and Inflammation on Patient Symptoms and Outcomes in Ovarian Cancer
Withdrawn NCT00551265 - Oregovomab With or Without Cyclophosphamide in Treating Patients With Stage III or Stage IV Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer That Responded to Second-Line Chemotherapy N/A
Completed NCT00093626 - Sorafenib in Treating Patients With Persistent or Recurrent Ovarian Epithelial or Peritoneal Cancer Phase 2
Completed NCT03367260 - The Treatment Preferences of Women Diagnosed With Ovarian Cancer
Recruiting NCT03983226 - Surgery and Niraparib in Secondary Recurrent Ovarian Cancer (SOC-3 Trial) Phase 2
Recruiting NCT03373058 - Efficacy of HIPEC in the Treatment of Advanced-Stage Epithelial Ovarian Cancer After Cytoreductive Surgery Phase 3