Temsirolimus, Carboplatin, and Paclitaxel as First-Line Therapy in Treating Patients With Newly Diagnosed Stage III-IV Clear Cell Ovarian Cancer

Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Conditions:	Ovarian Clear Cell Cystadenocarcinoma; Stage III Ovarian Cancer; Stage IV Ovarian Cancer
Interventions:	Drug: Carboplatin; Drug: Docetaxel; Other: Laboratory Biomarker Analysis; Drug: Paclitaxel; Drug: Temsirolimus

  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
The study was activated on 8/30/2010 and closed to accrual on 1/6/2014.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Additional details about the interventions administered were not included because these are groups (not arms).

Reporting Groups

	Description
US/Korea	Temsirolimus (CCI-779) 25mg IV Days 1 and 8, Carboplatin AUC= 6 IV Day 1 and Paclitaxel 175 mg/m2 IV on Day 1 every 3 weeks for cycles 1-6 or disease progression. Followed by consolidation therapy with temsirolimus (CCI-779) 25 mg weekly on Days 1, 8 and 15 every 3 weeks cycles 7-17 or until disease progression
Japan	Temsirolimus (CCI-779) 25mg IV Days 1 and 8, Carboplatin AUC= 6 IV Day 1 and Paclitaxel 175 mg/m2 IV on Day 1 every 3 weeks for cycles 1-6 or disease progression. Followed by consolidation therapy with temsirolimus (CCI-779) 25 mg weekly on Days 1, 8 and 15 every 3 weeks cycles 7-17 or until disease progression

Participant Flow:   Overall Study

	US/Korea	Japan
STARTED	45	45
COMPLETED	42	45
NOT COMPLETED	3	0
Ineligible - inadequate pathology	1	0
Ineligible - wrong cell type	1	0
Refused – Never Treated	1	0

  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.
Eligible and treated patients

Reporting Groups

	Description
US/Korea	Temsirolimus (CCI-779) 25mg IV Days 1 and 8, Carboplatin AUC= 6 IV Day 1 and Paclitaxel 175 mg/m2 IV on Day 1 every 3 weeks for cycles 1-6 or disease progression. Followed by consolidation therapy with temsirolimus (CCI-779) 25 mg weekly on Days 1, 8 and 15 every 3 weeks cycles 7-17 or until disease progression
Japan	Temsirolimus (CCI-779) 25mg IV Days 1 and 8, Carboplatin AUC= 6 IV Day 1 and Paclitaxel 175 mg/m2 IV on Day 1 every 3 weeks for cycles 1-6 or disease progression. Followed by consolidation therapy with temsirolimus (CCI-779) 25 mg weekly on Days 1, 8 and 15 every 3 weeks cycles 7-17 or until disease progression
Total	Total of all reporting groups

Baseline Measures

	US/Korea	Japan	Total
Overall Participants Analyzed; [Units: Participants]	42	45	87
Age, Customized; [Units: Participants]
20-29 years	1	1	2
30-39 years	2	3	5
40-49 years	12	9	21
50-59 years	21	21	42
60-69 years	6	8	14
70-79 years	0	3	3
80-89 years	0	0	0
Sex: Female, Male; [Units: Participants]; Count of Participants
Female	42 100.0%	45 100.0%	87 100.0%
Male	0 0.0%	0 0.0%	0 0.0%

  Outcome Measures

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1. Primary:

Proportion of Patients Who Are Alive and Progression-free for at Least 12 Months After Study Entry in Patients With Newly Diagnosed Stage III or IV Clear Cell Ovarian Cancer in the Following Populations: Patients in the U.S./Worldwide and Japan [ Time Frame: Tumor scans were done every other cycle for the first 6 months; then every 3 months x2; then every 6 months thereafter; and at any other time if clinically indicated or signs suggestive of progressive disease or rising levels; for up to 5 years. ]

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2. Primary:

Compare Progression-free Survival in Newly Diagnosed Stage III or IV Clear Cell Ovarian Cancer Patients in Patients in the U.S. and Worldwide (Outside of Japan) Versus Patients in Japan. [ Time Frame: Tumor scans were done every other cycle for the first 6 months;then every 3 mnths x2;then every 6 mnths thereafter; and at any other time if clinically indicated based on symptoms or physical signs suggesting progressive dx or rising serum tumor marker le ]

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3. Primary:

Frequency and Severity of Toxicity [ Time Frame: Each cycle while on treatment ]

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4. Secondary:

Progression-free Survival [ Time Frame: Tumor scans were done every other cycle for the first 6 months; then every 3 months x 2; then every 6 mths thereafter; and at any other time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising tumor mark ]

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5. Secondary:

Overall Survival [ Time Frame: Every cycle during treatment, then every 3 months for the first 2 years, then every six months for the next three years and then annually for the next 5 years. ]

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6. Secondary:

Objective Tumor Response [ Time Frame: Every other cycle for first 6 months; then every 3 months for two years; then every six months for the next three years; and at any other time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tu ]

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  Serious Adverse Events

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  Other Adverse Events

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  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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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: 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 less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo. 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. 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: Linda Gedeon for William Brady PhD
Organization: NRG Oncology Statistics and Data Management Center - Buffalo
phone: 716-845-5702
e-mail: lgedeon@nrgoncology.org

Responsible Party:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT01196429 History of Changes
Other Study ID Numbers:	NCI-2011-02653; NCI-2011-02653 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ); CDR0000684262; GOG-0268; GOG-0268 ( Other Identifier: NRG Oncology ); GOG-0268 ( Other Identifier: CTEP ); U10CA180868 ( U.S. NIH Grant/Contract ); U10CA027469 ( U.S. NIH Grant/Contract )
First Submitted:	September 4, 2010
First Posted:	September 8, 2010
Results First Submitted:	December 21, 2016
Results First Posted:	May 3, 2017
Last Update Posted:	June 12, 2017