TEACO: Taxotere, Eloxatin, Avastin in Cancer of the Ovary

• Sponsor: Sanofi (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00296816
• Collaborator: (none)
• Enrollment: 132
• Location: 1
• Arm: 1
• Duration (Months): 65
• Patients Per Site Per Month: 2

Study Details

Study Description

Brief Summary

Feasibility study to assess a novel combination of cytotoxic agents, docetaxel and oxaliplatin, as first-line therapy in the treatment of ovarian cancer and the impact of angiogenesis inhibition for the progression and prognosis of ovarian cancer by concurrent addition of bevacizumab (Avastin®).

Condition or Disease	Intervention/Treatment	Phase
Ovarian Cancer	Drug: Bevacizumab (Avastin®); Drug: Docetaxel (Taxotere®); Drug: Oxaliplatin (Eloxatin®)	Phase 2

Detailed Description

Participants were

• administered study medication approximately 28 days after initial surgery for ovarian cancer

• received the study treatment regimen of up to one year unless there was disease progression, unacceptable toxicity, death, participant refusal, or treatment delay beyond the time frame permitted for each treatment

Participants were followed for survival for a minimum 3 years from the date of enrollment

Study Design

• Study Type: Interventional
• Actual Enrollment: 132 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Pilot Phase II Study Evaluating the Combination of Oxaliplatin and Docetaxel With Bevacizumab as First Line Therapy in Patients With FIGO Stage IB-IV Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Carcinoma
• Study Start Date: Mar 1, 2006
• Actual Primary Completion Date: Aug 1, 2011
• Actual Study Completion Date: Aug 1, 2011

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Oxaliplatin/Docetaxel/Bevacizumab Participants with International Federation of Gynecology and Obstetrics (FIGO) stage IB through IV ovarian, primary peritoneal, or fallopian tube carcinoma treated with Oxaliplatin, Docetaxel, and Bevacizumab - 28 days after initial surgery

Drug: Bevacizumab (Avastin®); 15 mg/kg bevacizumab administered intravenously (IV) over 30 to 90 minutes on Day 1 of every 3 week cycle for 12 months or until disease progression or unacceptable toxicity; Drug: Docetaxel (Taxotere®); 75 mg/m^2 docetaxel was administered IV over 1 hour on Day 1 of every 3 week cycle for 6 cycles or until disease progression or unacceptable toxicity; Drug: Oxaliplatin (Eloxatin®); 85 mg/m^2 Oxaliplatin was administered IV over 2 hours on Day 1 of every 3 week cycle for 6 cycles or until disease progression or unacceptable toxicity

Outcome Measures

Primary Outcome Measures

1. Twelve-month Progression-free Survival (PFS) Rate in Participants [up to 12 months following treatment initiation]

   Tumor assessments were performed by Computed tomography (CT) and Magnetic Resonance Imaging (MRI) to evaluate disease progression based on Gynecologic Oncology Group (GOG) Response Evaluation Criteria in Solid Tumors (RECIST). Disease progression was recorded as any one of the following: appearance of a new lesion symptomatic deterioration progression of target or nontarget lesions death Participants who did not die or show show disease progression achieved PFS. PFS rate is the percent of participants who achieved PFS.

Secondary Outcome Measures

1. Twenty Four-month Progression-free Survival (PFS) Rate in Participants [up to 24 months following treatment initiation]

   Tumor assessments were performed by Computed tomography (CT) and Magnetic Resonance Imaging (MRI) to evaluate disease progression based on Gynecologic Oncology Group (GOG) Response Evaluation Criteria in Solid Tumors (RECIST). Disease progression was recorded as any one of the following: appearance of a new lesion symptomatic deterioration progression of target or nontarget lesions death Participants who did not die or show show disease progression achieved PFS. PFS rate is the percent of participants who achieved PFS.

2. Median Time to Progression-free Survival (PFS) [up to approximately 1300 days following treatment initiation]

   Time to PFS was the interval from the date of registration to the earliest date of disease progression or death, whichever occurred first. Time of PFS was censored on the last available tumor assessment date for participants leaving the study prior to disease progression or death; and also for participants requiring off-study medication or additional debulking surgery (where assessment date used was the one prior to off-study medication or surgery), at Day 1, for living participants with no post-baseline tumor assessments. Median PFS was estimated from a Kaplan-Meier curve.

3. Tumor Response Rate Based on Gynecologic Oncology Group (GOG) Response Evaluation Criteria in Solid Tumors (RECIST) [up to 12 months following treatment initiation]

   Tumors were assessed by CT and MRI. Tumor response was evaluated by GOG RECIST in which: Complete response (CR) was the disappearance of all target and non-target lesions, with no evidence of new lesions Partial response (PR) was at least a 30% decrease in the sum of longest dimensions (LD) of all measurable target lesions Participants with a response (CR or PR) were to have the initial response confirmed by tumor imaging in 4-6 weeks.

4. Twelve-month Recurrence-free Survival (RFS) Rate in Participants With Non Measurable Disease at Baseline [up to 12 months following treatment initiation]

   Participants with Recurrence-free survival (RFS) were participants with a non-measurable disease at baseline, who had not achieved disease progression nor had died. Disease progression included the following: the appearance of a new lesion symptomatic deterioration progression of non-target lesions a predefined serum CA 125 increase. RFS rate was the percent of participants in the non-measurable disease subgroup who achieved RFS.

5. Median Time to Recurrence-free Survival (RFS) in Participants With Non-measurable Disease at Baseline [up to approximately 1500 days following treatment initiation]

   The time to RFS was programmatically defined as the interval from the date of registration to the earliest date of disease progression or death, whichever occurred first. Participants were censored on the last available CA 125 biomarker blood draw date if left the study prior to disease progression or death they received off-study anti-tumor medication underwent debulking surgery censored at Day 1 if they were alive had no post baseline CA 125 biomarker blood draw.

6. CA-125 Response Rate [up to 12 months after treatment initiation]

   A CA-125 response was considered at least a 50% reduction in the level of the biomarker, CA-125, from a pretreatment level, which was confirmed and maintained for at least 28 days. The overall CA-125 biomarker response rate was defined as the number of participants in the measurable disease subgroup who met the above criteria at least once within the study treatment period +21 days, divided by the number of evaluable participants in the disease subgroup.

7. Overall Survival Rate [up to up to approximately 1700 days after treatment initiation]

   Survival was the observed length of life from entry into the study to death or the date of last contact. The overall survival rate (percentage of participants showing survival) at 12 and 24-months is reported here.

8. Median Overall Survival Time [up to approximately 1700 days after treatment initiation]

   Survival was the observed length of life from entry into the study to death or the date of last contact. The median overall survival time was estimated using Kaplan-Meier Curve.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

INCLUSION CRITERIA:

1. Females 18 years of age or older

2. Participants with a histologic diagnosis of ovarian, primary peritoneal, or fallopian tube carcinoma, Stage Ib- IV, with either optimal (≤ 1 cm residual disease) or suboptimal residual disease ( > 1 cm maximal diameter any remaining lesion) following initial surgery.

3. Participants with the following histologic epithelial cell types are eligible: Serious adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma,undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, transitional cell carcinoma, malignant Brenner's Tumor, or adenocarcinoma N.O.S.

4. Participant must have adequate bone marrow function

5. Participant must have adequate renal function

6. Participant must have adequate urine protein/creatinine reaction (UPC) of <1.0;

7. Participant must have adequate neurologic function

8. Hepatic function: Total Bilirubin ≤ ULN; AST and ALT and Alkaline Phosphatase must be within the range allowing for eligibility. In determining eligibility the more abnormal of the two values (AST or ALT) should be used.

9. Blood Coagulation parameters: PT such that international normalized ratio (INR) is < 1.5 (or an in-range INR, usually between 2 and 3, if a participant is on stable dose of therapeutic Warfarin or low molecular weight heparin) and a PTT < 1.2 times the upper limit normal.

10. Participants must be enrolled in the study prior to 50 days (every effort will be made for prior to 28 days) after initial surgery performed for the combined purpose of diagnosis, staging and cytoreduction.

11. Participants with measurable and non-measurable disease are eligible. Participants with suboptimal disease are eligible. Participants may or may not have cancer-related symptoms.

12. Participants who have met the pre-entry requirements specified including serologic measurement of CA-125 as a baseline for subsequent determination of response using Rustin criteria.

13. Participants with a GOG Performance Status of 0, 1, or 2.

EXCLUSION CRITERIA:

1. Participants with a current diagnosis of epithelial ovarian tumor of low malignant potential (Borderline carcinomas) are not eligible. Participants with a prior diagnosis of a low malignant potential tumor that was surgically resected and who subsequently develop invasive adenocarcinoma are eligible, provided that they have not received prior chemotherapy for any ovarian tumor.

2. Germ cell tumors, sex cord-stromal tumors, carcinosarcomas, mixed mullerian tumors or carcinosarcomas, metastatic carcinomas from other sites to the ovary and low malignant potential tumors including so called micropapillary serous carcinomas are not eligible.

3. Participants who have received prior radiotherapy to any portion of the abdominal cavity or pelvis are excluded. Prior radiation for localized cancer of the skin is permitted, provided that it was completed more than 5 years prior to enrollment, and the participant remains free of recurrent or metastatic disease.

4. Participants who have received any prior anticancer chemotherapy or biologic therapy for any malignancy are excluded.

5. Participants with synchronous primary endometrial cancer, or a past history of primary endometrial cancer, are excluded, unless all of the following conditions are met: Stage not greater than I-B; Less than 3 mm invasion without vascular or lymphatic invasion; No poorly differentiated subtypes, including papillary serous, clear cell, or other FIGO Grade 3 lesions.

6. Participants with any history of cancer, with the exception of inclusion criteria #2 and #3, and non-melanoma skin cancer, who are cancer free for the last 5 years, are excluded.

7. Participant with acute hepatitis or active infection that requires parenteral antibiotics.

8. Participants with serious, non-healing wound, ulcer, or bone fracture. This includes history of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 28 days.

Participants with granulating incisions healing by secondary intention with no evidence of fascial dehiscence or infection are eligible but require weekly wound examinations.

1. Participants with active bleeding or pathologic conditions that carry high risk of bleeding,such as known bleeding disorder, coagulopathy, or tumor involving major vessels.

2. Participants with history or evidence upon physical examination of CNS disease, including primary brain tumor, seizures not controlled with standard medical therapy, any brain metastases, or history of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within six months of the first date of treatment on this study.

3. Participants with clinically significant cardiovascular disease.

4. Participants with clinically significant proteinuria. Urine protein should be screened by urinalysis. Participants discovered to have a urine protein: serum creatinine ratio greater than or equal to 1 should undergo a 24-hour urine collection, which must be an adequate collection and must demonstrate < 1000 mg protein/24 hr to allow participation in the study.

5. Participants with or with anticipation of invasive procedures.

6. Participants with GOG Performance Grade of 3 or 4.

7. Participants who are pregnant or nursing.

8. Participants with known hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies and hypersensitivity to polysorbate 80 or hypersensitivity to any of the study drugs and its ingredients.

9. Participants who participated in a study with any investigational product/device within the last 30 days.

10. Any medical condition that in the judgment of the investigator would jeopardize any participant safety or the study drug evaluation for efficacy and safety.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sanofi-Aventis Administrative Office	Bridgewater	New Jersey	United States	08807

Sponsors and Collaborators

• Sanofi

Investigators

• Study Director: Phyllis Diener, BS, MT (ASCP), Sanofi

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sanofi
• ClinicalTrials.gov Identifier: NCT00296816
• Other Study ID Numbers: PM_L_0239
• First Posted: Feb 27, 2006
• Last Update Posted: Aug 23, 2012
• Last Verified: Aug 1, 2011

• Additional relevant MeSH terms: Bevacizumab; Docetaxel; Oxaliplatin

Study Results

Participant Flow

Recruitment Details	152 participants were screened for the study. 20 were screen failures. 132 participants met eligibity criteria and were treated with study medication.

Arm/Group Title	Oxaliplatin/Docetaxel/Bevacizumab
Arm/Group Description	Participants with International Federation of Gynecology and Obstetrics (FIGO) stage IB through IV ovarian, primary peritoneal, or fallopian tube carcinoma treated with Oxaliplatin, Docetaxel, and Bevacizumab - 28 days after initial surgery
Period Title: Overall Study
STARTED	132
COMPLETED	58
NOT COMPLETED	74

Baseline Characteristics

Arm/Group Title	Oxaliplatin/Docetaxel/Bevacizumab (Measurable Disease)	Oxaliplatin/Docetaxel/Bevacizumab (Non-Measurable Disease)	Total
Arm/Group Description	Participants with International Federation of Gynecology and Obstetrics (FIGO) stage IB through IV ovarian, primary peritoneal, or fallopian tube carcinoma treated with Oxaliplatin, Docetaxel, and Bevacizumab - 28 days after initial surgery, with a measurable disease at baseline. Measurable disease was defined as having at least one lesion that could be accurately measured in at least one dimension.	Participants with International Federation of Gynecology and Obstetrics (FIGO) stage IB through IV ovarian, primary peritoneal, or fallopian tube carcinoma treated with Oxaliplatin, Docetaxel, and Bevacizumab - 28 days after initial surgery, who did not have a measurable disease at baseline. Measurable disease was defined as having at least one lesion that could be accurately measured in at least one dimension.	Total of all reporting groups
Overall Participants	80	52	132
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	57.5 (10.43)	60.9 (9.54)	58.8 (10.19)
Sex: Female, Male (Count of Participants)
Female	80 100%	52 100%	132 100%
Male	0 0%	0 0%	0 0%
Primary Tumor Site (participants) [Number]
Ovary	65 81.3%	45 86.5%	110 83.3%
Fallopian tube	6 7.5%	5 9.6%	11 8.3%
Peritoneum	9 11.3%	2 3.8%	11 8.3%
FIGO stage at diagnosis (participants) [Number]
Stage IB	0 0%	0 0%	0 0%
Stage IC	0 0%	3 5.8%	3 2.3%
Stage IIA	0 0%	0 0%	0 0%
Stage IIB	0 0%	0 0%	0 0%
Stage IIC	3 3.8%	5 9.6%	8 6.1%
Stage IIIA	3 3.8%	2 3.8%	5 3.8%
Stage IIIB	2 2.5%	5 9.6%	7 5.3%
Stage IIIC	57 71.3%	32 61.5%	89 67.4%
Stage IV	15 18.8%	5 9.6%	20 15.2%

Outcome Measures

1. Primary Outcome

Title	Twelve-month Progression-free Survival (PFS) Rate in Participants
Description	Tumor assessments were performed by Computed tomography (CT) and Magnetic Resonance Imaging (MRI) to evaluate disease progression based on Gynecologic Oncology Group (GOG) Response Evaluation Criteria in Solid Tumors (RECIST). Disease progression was recorded as any one of the following: appearance of a new lesion symptomatic deterioration progression of target or nontarget lesions death Participants who did not die or show show disease progression achieved PFS. PFS rate is the percent of participants who achieved PFS.
Time Frame	up to 12 months following treatment initiation

Outcome Measure Data

Analysis Population Description

Intent-to-treat population with measurable disease at baseline - All participants with measurable disease at baseline who received study drugs, except for participants from one site which was closed prematurely, and for whom efficacy data was not available.

Arm/Group Title	Oxaliplatin/Docetaxel/Bevacizumab
Arm/Group Description	Participants with International Federation of Gynecology and Obstetrics (FIGO) stage IB through IV ovarian, primary peritoneal, or fallopian tube carcinoma treated with Oxaliplatin, Docetaxel, and Bevacizumab - 28 days after initial surgery
Measure Participants	70
Number (95% Confidence Interval) [percentage of participants]	65.7 82.1%

2. Secondary Outcome

Title	Twenty Four-month Progression-free Survival (PFS) Rate in Participants
Description	Tumor assessments were performed by Computed tomography (CT) and Magnetic Resonance Imaging (MRI) to evaluate disease progression based on Gynecologic Oncology Group (GOG) Response Evaluation Criteria in Solid Tumors (RECIST). Disease progression was recorded as any one of the following: appearance of a new lesion symptomatic deterioration progression of target or nontarget lesions death Participants who did not die or show show disease progression achieved PFS. PFS rate is the percent of participants who achieved PFS.
Time Frame	up to 24 months following treatment initiation

Outcome Measure Data

Analysis Population Description

Intent-to-treat population with measurable disease at baseline - All participants with measurable disease at baseline who received study drugs, except for participants from one site which was closed prematurely, and for whom efficacy data was not available.

Arm/Group Title	Oxaliplatin/Docetaxel/Bevacizumab
Arm/Group Description	Participants with International Federation of Gynecology and Obstetrics (FIGO) stage IB through IV ovarian, primary peritoneal, or fallopian tube carcinoma treated with Oxaliplatin, Docetaxel, and Bevacizumab - 28 days after initial surgery
Measure Participants	70
Number (95% Confidence Interval) [percentage of participants]	34.3 42.9%

3. Secondary Outcome

Title	Median Time to Progression-free Survival (PFS)
Description	Time to PFS was the interval from the date of registration to the earliest date of disease progression or death, whichever occurred first. Time of PFS was censored on the last available tumor assessment date for participants leaving the study prior to disease progression or death; and also for participants requiring off-study medication or additional debulking surgery (where assessment date used was the one prior to off-study medication or surgery), at Day 1, for living participants with no post-baseline tumor assessments. Median PFS was estimated from a Kaplan-Meier curve.
Time Frame	up to approximately 1300 days following treatment initiation

Outcome Measure Data

Analysis Population Description

Intent-to-treat population with measurable disease at baseline - All participants with measurable disease at baseline who received study drugs, except for participants from one site which was closed prematurely, and for whom efficacy data was not available.

Arm/Group Title	Oxaliplatin/Docetaxel/Bevacizumab
Arm/Group Description	Participants with International Federation of Gynecology and Obstetrics (FIGO) stage IB through IV ovarian, primary peritoneal, or fallopian tube carcinoma treated with Oxaliplatin, Docetaxel, and Bevacizumab - 28 days after initial surgery
Measure Participants	70
Median (95% Confidence Interval) [days]	495

4. Secondary Outcome

Title	Tumor Response Rate Based on Gynecologic Oncology Group (GOG) Response Evaluation Criteria in Solid Tumors (RECIST)
Description	Tumors were assessed by CT and MRI. Tumor response was evaluated by GOG RECIST in which: Complete response (CR) was the disappearance of all target and non-target lesions, with no evidence of new lesions Partial response (PR) was at least a 30% decrease in the sum of longest dimensions (LD) of all measurable target lesions Participants with a response (CR or PR) were to have the initial response confirmed by tumor imaging in 4-6 weeks.
Time Frame	up to 12 months following treatment initiation

Outcome Measure Data

Analysis Population Description

Intent-to-treat population with measurable disease at baseline - All participants with measurable disease at baseline who received study drugs, except for participants from one site which was closed prematurely, and for whom efficacy data was not available.

Arm/Group Title	Oxaliplatin/Docetaxel/Bevacizumab
Arm/Group Description	Participants with International Federation of Gynecology and Obstetrics (FIGO) stage IB through IV ovarian, primary peritoneal, or fallopian tube carcinoma treated with Oxaliplatin, Docetaxel, and Bevacizumab - 28 days after initial surgery
Measure Participants	70
Unconfirmed response (CR+PR)	51 63.8%
Unconfirmed complete response (CR)	23 28.8%
Unconfirmed partial response (PR)	28 35%
Unconfirmed progressive disease (PD)	5 6.3%
Confirmed response (CR+PR)	41 51.3%
Confirmed complete response (CR)	21 26.3%
Confirmed partial response (PR)	20 25%

5. Secondary Outcome

Title	Twelve-month Recurrence-free Survival (RFS) Rate in Participants With Non Measurable Disease at Baseline
Description	Participants with Recurrence-free survival (RFS) were participants with a non-measurable disease at baseline, who had not achieved disease progression nor had died. Disease progression included the following: the appearance of a new lesion symptomatic deterioration progression of non-target lesions a predefined serum CA 125 increase. RFS rate was the percent of participants in the non-measurable disease subgroup who achieved RFS.
Time Frame	up to 12 months following treatment initiation

Outcome Measure Data

Analysis Population Description

All participants with non-measurable disease at baseline, except for those at one site that closed prematurely, as their data was not available for efficacy measures.

Arm/Group Title	Oxaliplatin/Docetaxel/Bevacizumab
Arm/Group Description	Participants with International Federation of Gynecology and Obstetrics (FIGO) stage IB through IV ovarian, primary peritoneal, or fallopian tube carcinoma treated with Oxaliplatin, Docetaxel, and Bevacizumab - 28 days after initial surgery
Measure Participants	40
Number (95% Confidence Interval) [percentage of participants]	67.5 84.4%

6. Secondary Outcome

Title	Median Time to Recurrence-free Survival (RFS) in Participants With Non-measurable Disease at Baseline
Description	The time to RFS was programmatically defined as the interval from the date of registration to the earliest date of disease progression or death, whichever occurred first. Participants were censored on the last available CA 125 biomarker blood draw date if left the study prior to disease progression or death they received off-study anti-tumor medication underwent debulking surgery censored at Day 1 if they were alive had no post baseline CA 125 biomarker blood draw.
Time Frame	up to approximately 1500 days following treatment initiation

Outcome Measure Data

Analysis Population Description

All participants with non-measurable disease at baseline, except for those at one site that closed prematurely, as their data was not available for efficacy measures.

Arm/Group Title	Oxaliplatin/Docetaxel/Bevacizumab
Arm/Group Description	Participants with International Federation of Gynecology and Obstetrics (FIGO) stage IB through IV ovarian, primary peritoneal, or fallopian tube carcinoma treated with Oxaliplatin, Docetaxel, and Bevacizumab - 28 days after initial surgery
Measure Participants	40
Median (95% Confidence Interval) [days]	631

7. Secondary Outcome

Title	CA-125 Response Rate
Description	A CA-125 response was considered at least a 50% reduction in the level of the biomarker, CA-125, from a pretreatment level, which was confirmed and maintained for at least 28 days. The overall CA-125 biomarker response rate was defined as the number of participants in the measurable disease subgroup who met the above criteria at least once within the study treatment period +21 days, divided by the number of evaluable participants in the disease subgroup.
Time Frame	up to 12 months after treatment initiation

Outcome Measure Data

Analysis Population Description

All participants with non-measurable and measurable disease at baseline, and a pretreatment sample that was at least twice the ULN value for CA-125 within 2 weeks of first study treatment.

Arm/Group Title	Oxaliplatin/Docetaxel/Bevacizumab
Arm/Group Description	Participants with International Federation of Gynecology and Obstetrics (FIGO) stage IB through IV ovarian, primary peritoneal, or fallopian tube carcinoma treated with Oxaliplatin, Docetaxel, and Bevacizumab - 28 days after initial surgery
Measure Participants	80
With non-measurable disease at baseline (N=27)	81.5 101.9%
With measurable disease at baseline (N=53)	83.0 103.8%

8. Secondary Outcome

Title	Overall Survival Rate
Description	Survival was the observed length of life from entry into the study to death or the date of last contact. The overall survival rate (percentage of participants showing survival) at 12 and 24-months is reported here.
Time Frame	up to up to approximately 1700 days after treatment initiation

Outcome Measure Data

Analysis Population Description

Intent-to-treat population - All participants who received study drugs, except for participants from one site which was closed prematurely, and for whom efficacy data was not available.

Arm/Group Title	Oxaliplatin/Docetaxel/Bevacizumab
Arm/Group Description	Participants with International Federation of Gynecology and Obstetrics (FIGO) stage IB through IV ovarian, primary peritoneal, or fallopian tube carcinoma treated with Oxaliplatin, Docetaxel, and Bevacizumab - 28 days after initial surgery
Measure Participants	110
Overall survival at 12 months	85.5 106.9%
Overall survival at 24 months	71.8 89.8%

9. Secondary Outcome

Title	Median Overall Survival Time
Description	Survival was the observed length of life from entry into the study to death or the date of last contact. The median overall survival time was estimated using Kaplan-Meier Curve.
Time Frame	up to approximately 1700 days after treatment initiation

Outcome Measure Data

Analysis Population Description

Intent-to-treat population - All participants who received study drugs, except for participants from one site which was closed prematurely, and for whom efficacy data was not available.

Arm/Group Title	Oxaliplatin/Docetaxel/Bevacizumab
Arm/Group Description	Participants with International Federation of Gynecology and Obstetrics (FIGO) stage IB through IV ovarian, primary peritoneal, or fallopian tube carcinoma treated with Oxaliplatin, Docetaxel, and Bevacizumab - 28 days after initial surgery
Measure Participants	110
Median (90% Confidence Interval) [days]	1437.0

Adverse Events

Adverse Event Reporting Description	AEs were collected up to 30 days after the administration of the last study dose.
Arm/Group Title	Oxaliplatin/Docetaxel/Bevacizumab
Arm/Group Description	Participants with International Federation of Gynecology and Obstetrics (FIGO) stage IB through IV ovarian, primary peritoneal, or fallopian tube carcinoma treated with Oxaliplatin, Docetaxel, and Bevacizumab - 28 days after initial surgery
All Cause Mortality
	Oxaliplatin/Docetaxel/Bevacizumab
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Oxaliplatin/Docetaxel/Bevacizumab
	Affected / at Risk (%)	# Events
Total	33/132 (25%)
Blood and lymphatic system disorders
Febrile neutropenia	4/132 (3%)
Neutropenia	1/132 (0.8%)
Cardiac disorders
Cardiac failure congestive	1/132 (0.8%)
Supraventricular tachycardia	1/132 (0.8%)
Ear and labyrinth disorders
Vertigo positional	1/132 (0.8%)
Gastrointestinal disorders
Nausea	7/132 (5.3%)
Vomiting	7/132 (5.3%)
Small intestinal obstruction	5/132 (3.8%)
Abdominal pain	3/132 (2.3%)
Abdominal pain lower	1/132 (0.8%)
Abdominal pain upper	1/132 (0.8%)
Colitis	1/132 (0.8%)
Colonic fistula	1/132 (0.8%)
Diarrhoea	1/132 (0.8%)
Gastrointestinal haemorrhage	1/132 (0.8%)
Haematemesis	1/132 (0.8%)
Ileus	1/132 (0.8%)
Intestinal obstruction	1/132 (0.8%)
Intestinal perforation	1/132 (0.8%)
Peritoneal adhesions	1/132 (0.8%)
General disorders
Fatigue	1/132 (0.8%)
Non-cardiac chest pain	1/132 (0.8%)
Oedema peripheral	1/132 (0.8%)
Pain	1/132 (0.8%)
Pyrexia	1/132 (0.8%)
Hepatobiliary disorders
Bile duct obstruction	1/132 (0.8%)
Cholangitis	1/132 (0.8%)
Portal vein thrombosis	1/132 (0.8%)
Infections and infestations
Abdominal abscess	1/132 (0.8%)
Pneumonia	1/132 (0.8%)
Urinary tract infection	1/132 (0.8%)
Wound infection	1/132 (0.8%)
Injury, poisoning and procedural complications
Subdural haematoma	1/132 (0.8%)
Metabolism and nutrition disorders
Dehydration	3/132 (2.3%)
Decreased appetite	1/132 (0.8%)
Hypoglycaemia	1/132 (0.8%)
Nervous system disorders
Encephalopathy	1/132 (0.8%)
Transient ischaemic attack	1/132 (0.8%)
Renal and urinary disorders
Cystitis haemorrhagic	1/132 (0.8%)
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism	5/132 (3.8%)
Vascular disorders
Hypertension	1/132 (0.8%)
Poor venous access	1/132 (0.8%)
Venous thrombosis	1/132 (0.8%)
Other (Not Including Serious) Adverse Events
	Oxaliplatin/Docetaxel/Bevacizumab
	Affected / at Risk (%)	# Events
Total	130/132 (98.5%)
Blood and lymphatic system disorders
Neutropenia	59/132 (44.7%)
Leukopenia	31/132 (23.5%)
Anaemia	18/132 (13.6%)
Lymphopenia	13/132 (9.8%)
Eye disorders
Lacrimation increased	35/132 (26.5%)
Vision blurred	10/132 (7.6%)
Gastrointestinal disorders
Nausea	85/132 (64.4%)
Diarrhoea	77/132 (58.3%)
Constipation	59/132 (44.7%)
Vomiting	42/132 (31.8%)
Abdominal pain	37/132 (28%)
Stomatitis	26/132 (19.7%)
Abdominal discomfort	11/132 (8.3%)
Abdominal pain lower	10/132 (7.6%)
Dysphagia	10/132 (7.6%)
Gingival bleeding	10/132 (7.6%)
Oral pain	10/132 (7.6%)
Abdominal distension	8/132 (6.1%)
Dyspepsia	8/132 (6.1%)
Flatulence	8/132 (6.1%)
Abdominal pain upper	7/132 (5.3%)
General disorders
Fatigue	101/132 (76.5%)
Oedema peripheral	19/132 (14.4%)
Asthenia	12/132 (9.1%)
Pain	12/132 (9.1%)
Malaise	11/132 (8.3%)
Pyrexia	10/132 (7.6%)
Chest pain	9/132 (6.8%)
Mucosal inflammation	9/132 (6.8%)
Temperature intolerance	9/132 (6.8%)
Immune system disorders
Hypersensitivity	8/132 (6.1%)
Infections and infestations
Urinary tract infection	30/132 (22.7%)
Upper respiratory tract infection	14/132 (10.6%)
Sinusitis	11/132 (8.3%)
Rhinitis	10/132 (7.6%)
Nasopharyngitis	7/132 (5.3%)
Investigations
Alanine aminotransferase increased	12/132 (9.1%)
Aspartate aminotransferase increased	12/132 (9.1%)
Neutrophil count	12/132 (9.1%)
Blood alkaline phosphatase increased	10/132 (7.6%)
Weight decreased	7/132 (5.3%)
Metabolism and nutrition disorders
Decreased appetite	44/132 (33.3%)
Hypokalaemia	11/132 (8.3%)
Dehydration	7/132 (5.3%)
Musculoskeletal and connective tissue disorders
Arthralgia	47/132 (35.6%)
Back pain	26/132 (19.7%)
Myalgia	23/132 (17.4%)
Pain in extremity	16/132 (12.1%)
Musculoskeletal pain	14/132 (10.6%)
Bone pain	13/132 (9.8%)
Muscle spasms	7/132 (5.3%)
Nervous system disorders
Neuropathy peripheral	64/132 (48.5%)
Headache	40/132 (30.3%)
Peripheral sensory neuropathy	33/132 (25%)
Dysgeusia	31/132 (23.5%)
Paraesthesia	26/132 (19.7%)
Dizziness	24/132 (18.2%)
Hypoaesthesia	8/132 (6.1%)
Psychiatric disorders
Insomnia	20/132 (15.2%)
Depression	19/132 (14.4%)
Anxiety	9/132 (6.8%)
Renal and urinary disorders
Proteinuria	11/132 (8.3%)
Dysuria	10/132 (7.6%)
Reproductive system and breast disorders
Vaginal haemorrhage	7/132 (5.3%)
Respiratory, thoracic and mediastinal disorders
Epistaxis	39/132 (29.5%)
Cough	19/132 (14.4%)
Dyspnoea	19/132 (14.4%)
Dysphonia	12/132 (9.1%)
Oropharyngeal pain	10/132 (7.6%)
Rhinorrhoea	10/132 (7.6%)
Skin and subcutaneous tissue disorders
Alopecia	86/132 (65.2%)
Nail disorder	33/132 (25%)
Rash	17/132 (12.9%)
Dry skin	15/132 (11.4%)
Nail discolouration	9/132 (6.8%)
Pruritus	7/132 (5.3%)
Vascular disorders
Hypertension	31/132 (23.5%)
Flushing	14/132 (10.6%)
Hot flush	10/132 (7.6%)

Limitations/Caveats

One site closed prematurely during the study. Every effort was made to collect, at minimum, any outstanding safety data for the participants at this site. As a result, participants from this site were included only in the safety analysis.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The sponsor encourages the publication of the results of their studies, using only clean, checked and validated data in order to ensure the accuracy of the results. At least 45 days in advance of proposed submission, the Investigator should forward a copy of the manuscript or abstract for review by the sponsor, and, if necessary, delay publication or communication for a limited time in order to protect the confidentiality or proprietary nature of any information contained therein.