Erlotinib Plus Carboplatin and Paclitaxel in Ovarian Carcinoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00059787
First received: May 6, 2003
Last updated: October 29, 2015
Last verified: May 2013
Results First Received: April 29, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Brenner Tumor
Fallopian Tube Cancer
Ovarian Clear Cell Cystadenocarcinoma
Ovarian Endometrioid Adenocarcinoma
Ovarian Mucinous Cystadenocarcinoma
Ovarian Serous Cystadenocarcinoma
Ovarian Undifferentiated Adenocarcinoma
Stage III Ovarian Epithelial Cancer
Stage IV Ovarian Epithelial Cancer
Interventions: Drug: paclitaxel
Drug: carboplatin
Drug: erlotinib

  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
A total of 56 patients were enrolled between June 2003 and December 2006.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Treatment (Paclitaxel, Carboplatin, Erlotinib Hydrochloride)

Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Patients also receive oral erlotinib daily. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a pathologic complete response, those initially suboptimally debulked with a response, and patients who elect not to undergo surgical reassessment but who achieve a complete clinical response receive maintenance erlotinib for an additional 12 months.

paclitaxel: Given IV

carboplatin: Given IV

erlotinib hydrochloride: Given PO

laboratory biomarker analysis: Correlative studies


Participant Flow:   Overall Study
    Treatment (Paclitaxel, Carboplatin, Erlotinib Hydrochloride)  
STARTED     56  
COMPLETED     36  
NOT COMPLETED     20  
Adverse Event                 13  
disease progression                 2  
ineligible                 1  
unknown                 4  



  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
Treatment (Paclitaxel, Carboplatin, Erlotinib Hydrochloride)

Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Patients also receive oral erlotinib daily. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a pathologic complete response, those initially suboptimally debulked with a response, and patients who elect not to undergo surgical reassessment but who achieve a complete clinical response receive maintenance erlotinib for an additional 12 months.

paclitaxel: Given IV

carboplatin: Given IV

erlotinib hydrochloride: Given PO

laboratory biomarker analysis: Correlative studies


Baseline Measures
    Treatment (Paclitaxel, Carboplatin, Erlotinib Hydrochloride)  
Number of Participants  
[units: participants]
  56  
Age  
[units: years]
Median (Full Range)
  55.5  
  (22 to 79)  
Gender  
[units: participants]
 
Female     56  
Male     0  
Race/Ethnicity, Customized  
[units: participants]
 
Black     2  
Asian     5  
White     42  
Other     7  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Pathologic Complete Response Rates   [ Time Frame: Up to 7 years ]

2.  Primary:   The Percentage of Participants Experiencing Toxicty (Grade 2 and Grade 3/4) Associated With the Combined Regimen   [ Time Frame: For the duration of the study up to 7 years ]

3.  Secondary:   To Measure EGFR Gene Amplification in Tumor Specimens   [ Time Frame: The duration of the study for up to 7 years ]

4.  Secondary:   To Determine Progession Free Survival With the Addition of OSI-774 (Tarceva) to the Combination of Paclitaxel and Carboplatin   [ Time Frame: The duration of the study ]

5.  Secondary:   To Determine the Tolerability of Twelve Months of Maintenance Treatment   [ Time Frame: Twelve months of maintenance ]


  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: NYCC Regulatory Coordinator
Organization: Montefiore Medical Center - New York Cancer Consortium
phone: 718-379-6862
e-mail: sforde@montefiore.org


Publications of Results:

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00059787     History of Changes
Other Study ID Numbers: NCI-2013-00026
NYU 02-30 ( Other Identifier: New York University )
N01CM62204 ( US NIH Grant/Contract Award Number )
Study First Received: May 6, 2003
Results First Received: April 29, 2015
Last Updated: October 29, 2015
Health Authority: United States: Food and Drug Administration