VEGF Trap and Docetaxel in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00436501
First received: February 15, 2007
Last updated: March 11, 2015
Last verified: March 2013
Results First Received: January 29, 2015  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Fallopian Tube Cancer
Malignant Tumor of Peritoneum
Recurrent Ovarian Epithelial Cancer
Interventions: Drug: docetaxel
Biological: ziv-aflibercept
Other: laboratory biomarker analysis
Other: pharmacological study

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment Period: January 18, 2007 to September 27, 2010. All recruitment done in medical clinic settings.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of 58 total participants enrolled at multiple sites, three in the Phase II portion of the study were excluded from the trial.

Reporting Groups
  Description
Phase I VEGF Trap, Docetaxel Phase I VEGF Trap starting dose 2 mg/kg intravenous (IV) over 1 hour on day 1 of course 1, then VEGF Trap IV and Docetaxel 75 mg/m^2 IV over 1 hour on day 1 in all subsequent courses. Courses repeat every 21 days. Escalating doses of VEGF Trap (2, 4, or 6 mg/kg) until maximum tolerated dose (MTD) determined.
Phase II: VEGF Trap, Docetaxel Phase II VEGF Trap 6 mg/kg (the MTD determined in Phase I) and Docetaxel 75 mg/m^2 as in Phase I. Courses repeat every 21 days.

Participant Flow for 3 periods

Period 1:   Complete Study Participation
    Phase I VEGF Trap, Docetaxel     Phase II: VEGF Trap, Docetaxel  
STARTED     9 [1]   49 [2]
COMPLETED     9     49  
NOT COMPLETED     0     0  
[1] Phase 1 opened on January 17, 2007 and closed to new patient entry on March 7, 2008.
[2] After toxicity observations, Phase 2 opened June 4, 2008 and closed September 27, 2010.

Period 2:   Phase 1: VEGF Trap Escalating Dose
    Phase I VEGF Trap, Docetaxel     Phase II: VEGF Trap, Docetaxel  
STARTED     9 [1]   0 [2]
COMPLETED     9     0  
NOT COMPLETED     0     0  
[1] Phase 1 opened on January 17, 2007 and closed to new patient entry on March 7, 2008.
[2] Participants registered in next period.

Period 3:   Phase 2: MTD VEGF Trap + Docetaxel
    Phase I VEGF Trap, Docetaxel     Phase II: VEGF Trap, Docetaxel  
STARTED     0     49 [1]
COMPLETED     0     46  
NOT COMPLETED     0     3  
Withdrawal by Subject                 0                 2  
Incomplete Assessment                 0                 1  
[1] After toxicity observations Phase 2 opened June 4, 2008 and closed to entry September 27, 2010.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Phase I VEGF Trap, Docetaxel Phase I VEGF Trap starting dose 2 mg/kg intravenous (IV) over 1 hour on day 1 of course 1, then VEGF Trap IV and Docetaxel 75 mg/m^2 IV over 1 hour on day 1 in all subsequent courses. Courses repeat every 21 days. Escalating doses of VEGF Trap (2, 4, or 6 mg/kg) until maximum tolerated dose (MTD) determined.
Phase II VEGF Trap, Docetaxel Phase II VEGF Trap 6 mg/kg (the MTD determined in Phase I) and Docetaxel 75 mg/m^2 as in Phase I. Courses repeat every 21 days.
Total Total of all reporting groups

Baseline Measures
    Phase I VEGF Trap, Docetaxel     Phase II VEGF Trap, Docetaxel     Total  
Number of Participants  
[units: participants]
  9     46     55  
Age  
[units: years]
Median (Full Range)
  59    (49 to 71)     58    (38 to 80)     58    (38 to 80)  
Gender  
[units: participants]
     
Female     9     46     55  
Male     0     0     0  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     0     2     2  
Not Hispanic or Latino     9     44     53  
Unknown or Not Reported     0     0     0  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     1     0     1  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     1     1     2  
White     7     45     52  
More than one race     0     0     0  
Unknown or Not Reported     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     9     46     55  
Participant Cancer Histology [1]
[units: participants]
     
Adenocarcinoma     0     3     3  
Clear cell     1     4     5  
Endometrioid     0     1     1  
Mixed     0     5     5  
Serous     6     31     37  
Transitional cell     2     0     2  
Unclassified     0     2     2  
[1] Histological classification of participant cancer based on pathology report from most recent pre-registration diagnostic biopsy or surgery, confirmed within 14 days after registration for baseline measurements/data.



  Outcome Measures
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1.  Primary:   Maximum Tolerated Dose of VEGF Trap (Phase I)   [ Time Frame: 21 day cycle, up to 3 cycles ]

2.  Primary:   Number of Participants With Clinical Response (Partial Response or Complete Response) According to the Response Evaluation Criteria in Solid Tumors (RECIST)   [ Time Frame: Up to 6 months ]

3.  Primary:   Median Overall Survival (OS) (Phase II)   [ Time Frame: Time from start of treatment to time of progression, assessed up to 6 years. ]

4.  Primary:   Overall Objective Response Rate According to RECIST (Phase II)   [ Time Frame: Up to 6 months ]

5.  Primary:   Median Progression-Free Survival (PFS) (Phase II)   [ Time Frame: Time from start of treatment to time of progression, assessed up to 6 years. ]

6.  Secondary:   Overall Median Duration of Response (Phase II)   [ Time Frame: Response assessed following treatment (every 3 weeks), up to 6 years. Study duration January 2007 to May 2013. ]

7.  Secondary:   Frequency and Severity of Adverse Effects of Treatment as Assessed by NCI CTCAE v3.0 (Phase II)   [ Time Frame: Up to 6 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

8.  Secondary:   Proportion of Patients With PFS (Phase II)   [ Time Frame: 6 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Robert Coleman, MD / Professor
Organization: UT MD Anderson Cancer Center, Office of Multicenter Clinical Research
e-mail: CR_Study_Registration@mdanderson.org


No publications provided by National Cancer Institute (NCI)

Publications automatically indexed to this study:

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00436501     History of Changes
Obsolete Identifiers: NCT00427518
Other Study ID Numbers: NCI-2009-00218, 2006-0329, P50CA083639
Study First Received: February 15, 2007
Results First Received: January 29, 2015
Last Updated: March 11, 2015
Health Authority: United States: Food and Drug Administration