ClinicalTrials.gov
ClinicalTrials.gov Menu

Carboplatin, Paclitaxel, and Surgery in Treating Patients With Advanced Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cavity 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. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00331422
Recruitment Status : Terminated (Study was terminated due to lack of available funding.)
First Posted : May 31, 2006
Results First Posted : February 8, 2010
Last Update Posted : December 28, 2017
Sponsor:
Information provided by (Responsible Party):
Masonic Cancer Center, University of Minnesota

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Fallopian Tube Cancer
Ovarian Cancer
Peritoneal Cavity Cancer
Interventions Drug: carboplatin
Drug: paclitaxel
Procedure: cytoreductive surgery
Enrollment 7
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Patients Who Received Treatment
Hide Arm/Group Description Includes all patients enrolled and treated with at least one dose of chemotherapy (carboplatin - dose calculated per Calvert formula - given intravenously for 30 minutes and/or paclitaxel 175 milligrams per meter squared over 3 hours).
Period Title: Overall Study
Started 7 [1]
Completed 2 [2]
Not Completed 5
Reason Not Completed
Did not receive entire study regimen             5
[1]
Patients who met study criteria and received at least one dose of study drug.
[2]
Completed all 6 courses of chemotherapy and had surgery to remove all tumor lesions.
Arm/Group Title Patients Who Received Treatment
Hide Arm/Group Description Includes all patients enrolled and treated with at least one dose of chemotherapy (carboplatin - dose calculated per Calvert formula - given intravenously for 30 minutes and/or paclitaxel 175 milligrams per meter squared over 3 hours).
Overall Number of Baseline Participants 7
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants
<=18 years
0
   0.0%
Between 18 and 65 years
3
  42.9%
>=65 years
4
  57.1%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 7 participants
67
(57 to 80)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants
Female
7
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 7 participants
7
1.Primary Outcome
Title Number of Patients Who Underwent Optimal Cytoreduction After Chemotherapy
Hide Description These patients had their tumor(s) removed by surgery after receiving 4 cycles of chemotherapy to determine their response.
Time Frame Week 18 (After 4 cycles of chemotherapy)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Includes those patients that received 4 cycles of therapy before removal of cancerous tissue. Evaluation of overall response is not possible due to low number of patients and therefore could not obtain statistical significance.
Arm/Group Title Evaluable Patients (Received 4 Cycles of Therapy and Surgery)
Hide Arm/Group Description:
Includes patients treated with 4 cycles of study chemotherapy regimen and surgery.
Overall Number of Participants Analyzed 2
Measure Type: Number
Unit of Measure: Participants
2
2.Secondary Outcome
Title Patients' Overall Tumor Response as Measured by Response Evaluation Criteria in Solid Tumors (RECIST)
Hide Description Best response recorded from start of treatment until after 4th cycle of treatment. Defined by the sum of Complete Responses (CR), Partial Responses (PR), and Stable Disease (SD) in patients neoadjuvant chemotherapy. CR=disappearance of all lesions, PR=>or=30% decrease in sumof all target lesins, Progressive Disease (PD) =>or =20% increase in sum of all target or any new lesions, SD=not CR, PR or PD.
Time Frame Week 16 (4 weeks after 4th course)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Patients Who Received Treatment
Hide Arm/Group Description:
Includes all patients enrolled and treated with at least one dose of chemotherapy (carboplatin - dose calculated per Calvert formula - given intravenously for 30 minutes and/or paclitaxel 175 milligrams per meter squared over 3 hours).
Overall Number of Participants Analyzed 7
Measure Type: Number
Unit of Measure: Participants
Partial Response 2
Progressive Disease 3
Stable Disease 2
3.Secondary Outcome
Title Clinical Response Based on Serum Cancer Antigen 125 (CA-125) Concentration
Hide Description Ca-125 serum results compared from baseline to after patient's last treatment. This is a tumor biomarker. A decrease in results indicates a clinical response.
Time Frame From Baseline to up to 12 weeks (4 courses of therapy)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Patients Who Received Treatment
Hide Arm/Group Description:
Includes all patients enrolled and treated with at least one dose of chemotherapy (carboplatin - dose calculated per Calvert formula - given intravenously for 30 minutes and/or paclitaxel 175 milligrams per meter squared over 3 hours).
Overall Number of Participants Analyzed 7
Measure Type: Number
Unit of Measure: Participants
Increased Concentration 1
Decreased Concentration 6
4.Secondary Outcome
Title Change in Drug Resistance After Neoadjuvant Chemotherapy
Hide Description As measured by extreme drug resistance assay - Unable to report due to tissue samples being incomplete or unsatisfactory to do laboratory testing.
Time Frame Day 1 to Time to Surgery (Approximately Week 18)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Patients Who Received Treatment
Hide Arm/Group Description:
Includes all patients enrolled and treated with at least one dose of chemotherapy (carboplatin - dose calculated per Calvert formula - given intravenously for 30 minutes and/or paclitaxel 175 milligrams per meter squared over 3 hours).
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Change in Thrombospondin-1 (TSP-1), p53, and Tumor Vessel Density
Hide Description Unable to report due to incomplete (nonviable) or unsatisfactory tissue samples.
Time Frame Week 18 (At surgery)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Patients Who Received Treatment
Hide Arm/Group Description:
Includes all patients enrolled and treated with at least one dose of chemotherapy (carboplatin - dose calculated per Calvert formula - given intravenously for 30 minutes and/or paclitaxel 175 milligrams per meter squared over 3 hours).
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Quality of Life Score of Patients Receiving Neoadjuvant Chemotherapy
Hide Description

Functional Assessment of Cancer Therapy-Ovarian (FACT-O) Questionnaire was used to assess the impact of treatment- and disease-related factors on the quality of life of patients with ovarian cancers undergoing chemotherapy. It is a 5 point scale (from worse to best: 0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much responses). Physical well-being, social/family well-being, functional well-being, emotional well-being and additional concerns questions are asked.

Unable to evaluate; patients did not consistently complete the questionnaires.

Time Frame Day 1, Week 12 (after 4th course) , Week 16 (4 weeks after last treatment)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Patients Who Received Treatment
Hide Arm/Group Description:
Includes all patients enrolled and treated with at least one dose of chemotherapy (carboplatin - dose calculated per Calvert formula - given intravenously for 30 minutes and/or paclitaxel 175 milligrams per meter squared over 3 hours).
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Adverse events were collected from Day 1 of treatment through 30 days post treatment or death, whichever came first.
Adverse Event Reporting Description All events are reported; related and unrelated to study treatment.
 
Arm/Group Title Patients Who Received Treatment
Hide Arm/Group Description Includes all patients enrolled and treated with at least one dose of chemotherapy (carboplatin - dose calculated per Calvert formula - given intravenously for 30 minutes and/or paclitaxel 175 milligrams per meter squared over 3 hours).
All-Cause Mortality
Patients Who Received Treatment
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Patients Who Received Treatment
Affected / at Risk (%) # Events
Total   6/7 (85.71%)    
Cardiac disorders   
Myocardial infarction * 1  1/7 (14.29%)  1
Gastrointestinal disorders   
Abdominal pain * 1  1/7 (14.29%)  1
Bowel obstruction * 1  3/7 (42.86%)  3
Dehydration * 1  1/7 (14.29%)  1
Diarrhea * 1  1/7 (14.29%)  1
Fistula, gastrointestinal * 1  1/7 (14.29%)  1
Hemorrhage * 1  1/7 (14.29%)  1
Nausea * 1  1/7 (14.29%)  1
General disorders   
Other, Failure to Thrive * 1  1/7 (14.29%)  1
Pain * 1  1/7 (14.29%)  1
Infections and infestations   
Infection * 1  2/7 (28.57%)  4
Nervous system disorders   
Anxiety * 1  1/7 (14.29%)  1
Confusion * 1  1/7 (14.29%)  1
Neuropathy * 1  1/7 (14.29%)  1
Renal and urinary disorders   
Hydronephrosis * 1  1/7 (14.29%)  1
Infection, bladder * 1  1/7 (14.29%)  1
Renal insufficiency * 1  1/7 (14.29%)  1
Respiratory, thoracic and mediastinal disorders   
Dyspnea * 1  1/7 (14.29%)  1
Epistaxis * 1  1/7 (14.29%)  1
Skin and subcutaneous tissue disorders   
Wound complication * 1  3/7 (42.86%)  3
Vascular disorders   
Pulmonary embolism * 1  2/7 (28.57%)  2
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Patients Who Received Treatment
Affected / at Risk (%) # Events
Total   7/7 (100.00%)    
Blood and lymphatic system disorders   
Anemia * 1  2/7 (28.57%)  2
Neutropenia * 1  4/7 (57.14%)  4
Peripheral Edema (limb) * 1  1/7 (14.29%)  1
Thrombocytopenia * 1  3/7 (42.86%)  3
Ear and labyrinth disorders   
Tinnitus (ringing in ears) * 1  1/7 (14.29%)  1
Eye disorders   
Double Vision * 1  1/7 (14.29%)  1
Gastrointestinal disorders   
Diarrhea * 1  1/7 (14.29%)  1
General disorders   
Fatigue * 1  2/7 (28.57%)  2
Infection * 1  1/7 (14.29%)  1
Pain * 1  1/7 (14.29%)  1
Musculoskeletal and connective tissue disorders   
Hip Pain * 1  1/7 (14.29%)  1
Nervous system disorders   
Anxiety * 1  2/7 (28.57%)  2
Sleep Apnea * 1  1/7 (14.29%)  1
Respiratory, thoracic and mediastinal disorders   
Oxygen, decreased (pulmonary-atelectasis) * 1  1/7 (14.29%)  1
Skin and subcutaneous tissue disorders   
Alopecia * 1  7/7 (100.00%)  7
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (3.0)
1 of the 2 evaluable patients was switched from Paclitaxel to Taxotere during the course of her treatment due to toxicity (adverse effects), but since it remains a platinum-based chemotherapy she is included in the evaluable group.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Melissa Geller, MD
Organization: Masonic Cancer Center, University of Minnesota
Phone: 612-626-3111
Responsible Party: Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier: NCT00331422     History of Changes
Other Study ID Numbers: 2004LS070
UMN-0409M64006 ( Other Identifier: Institutional Review Board, University of Minnesota )
UMN- WCC-40 ( Other Identifier: Women's Cancer Center, University of Minnesota )
First Submitted: May 30, 2006
First Posted: May 31, 2006
Results First Submitted: November 23, 2009
Results First Posted: February 8, 2010
Last Update Posted: December 28, 2017