Trial Outcomes & Findings for Sorafenib With or Without Paclitaxel and Carboplatin in Treating Patients With Recurrent Ovarian Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer (NCT NCT00096200)

Last Updated: 2022-02-08

Results Overview

Patients should be reevaluated for response every 2 cycles (6 weeks). Patients who continue on Arm A of treatment for more than 12 months should be reevaluated for response every 3 cycles (9 weeks). In addition to a baseline scan, confirmatory scans should also be obtained 4 weeks following initial documentation of objective response.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

44 participants

Primary outcome timeframe

after 6 weeks (2 cycles)

Results posted on

2022-02-08

Participant Flow

Patients accrued from medical clinic from August 2004 through June 2011

Participant milestones

Participant milestones
Measure	Arm A Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression crossover to arm II	Arm B Patients receive oral sorafenib twice daily on days 2-19. Patients also receive carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.	Arm C Patients from Arm A that had progressive disease were eligible to crossover to Arm B
Overall Study STARTED	9	30	5
Overall Study COMPLETED	8	23	5
Overall Study NOT COMPLETED	1	7	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm A Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression crossover to arm II	Arm B Patients receive oral sorafenib twice daily on days 2-19. Patients also receive carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Overall Study Adverse Event	0	4
Overall Study Withdrawal by Subject	1	2
Overall Study Ineligible pathology	0	1

Baseline Characteristics

Sorafenib With or Without Paclitaxel and Carboplatin in Treating Patients With Recurrent Ovarian Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm A n=9 Participants Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression crossover to arm II	Arm B n=30 Participants Patients receive oral sorafenib twice daily on days 2-19. Patients also receive carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.	Arm C n=5 Participants Patients from Arm A that had progressive disease were eligible to crossover to Arm B	Total n=44 Participants Total of all reporting groups
Age, Customized Age 40-49	0 participants n=39 Participants	2 participants n=41 Participants	0 participants n=35 Participants	2 participants n=31 Participants
Age, Customized Age 50-59	4 participants n=39 Participants	15 participants n=41 Participants	0 participants n=35 Participants	19 participants n=31 Participants
Age, Customized Age 60-69	4 participants n=39 Participants	8 participants n=41 Participants	5 participants n=35 Participants	17 participants n=31 Participants
Age, Customized Age 70-79	1 participants n=39 Participants	5 participants n=41 Participants	0 participants n=35 Participants	6 participants n=31 Participants
Sex: Female, Male Female	9 Participants n=39 Participants	30 Participants n=41 Participants	5 Participants n=35 Participants	44 Participants n=31 Participants
Sex: Female, Male Male	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants	0 Participants n=31 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants	0 Participants n=31 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	8 Participants n=39 Participants	22 Participants n=41 Participants	5 Participants n=35 Participants	35 Participants n=31 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=39 Participants	8 Participants n=41 Participants	0 Participants n=35 Participants	9 Participants n=31 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants	0 Participants n=31 Participants
Race (NIH/OMB) Asian	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants	0 Participants n=31 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants	0 Participants n=31 Participants
Race (NIH/OMB) Black or African American	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants	0 Participants n=31 Participants
Race (NIH/OMB) White	9 Participants n=39 Participants	24 Participants n=41 Participants	5 Participants n=35 Participants	38 Participants n=31 Participants
Race (NIH/OMB) More than one race	0 Participants n=39 Participants	1 Participants n=41 Participants	0 Participants n=35 Participants	1 Participants n=31 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=39 Participants	5 Participants n=41 Participants	0 Participants n=35 Participants	5 Participants n=31 Participants
Region of Enrollment United States	9 participants n=39 Participants	30 participants n=41 Participants	5 participants n=35 Participants	44 participants n=31 Participants

PRIMARY outcome

Timeframe: after 6 weeks (2 cycles)

Population: Patients that received 2 cycles of treatment. Includes results from patients that crossed over to Arm C.

Outcome measures

Outcome measures
Measure	Arm A n=13 Participants Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression after 2 cycles of treatment may crossover to arm B.	Arm B n=23 Participants Patients receive oral sorafenib twice daily on days 2-19. Patients also receive carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.	Arm C: Crossover From Arm A to B n=5 Participants Cross-over arm: Patients receive oral sorafenib twice daily on days 2-19. Patients also receive carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Complete and Partial Response Rate Using the Response Evaluation Criteria in Solid Tumors (RECIST) Criteria Partial Response	2 participants	11 participants	1 participants
Complete and Partial Response Rate Using the Response Evaluation Criteria in Solid Tumors (RECIST) Criteria Progressive Disease	8 participants	1 participants	0 participants
Complete and Partial Response Rate Using the Response Evaluation Criteria in Solid Tumors (RECIST) Criteria Stable Disease	3 participants	7 participants	4 participants
Complete and Partial Response Rate Using the Response Evaluation Criteria in Solid Tumors (RECIST) Criteria Complete Response	0 participants	4 participants	0 participants

SECONDARY outcome

Timeframe: up to 85 months of follow-up

Population: Subjects who completed at least 2 cycles of therapy

Progression free survival (PFS) was measured by months from the date of treatment to the date of death or the date of progression, and censored at the date of last follow-up for those alive without progression.

Outcome measures

Outcome measures
Measure	Arm A n=13 Participants Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression after 2 cycles of treatment may crossover to arm B.	Arm B n=23 Participants Patients receive oral sorafenib twice daily on days 2-19. Patients also receive carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.	Arm C: Crossover From Arm A to B n=5 Participants Cross-over arm: Patients receive oral sorafenib twice daily on days 2-19. Patients also receive carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Evaluate the Progression-free Survival Rate	5.6 months Interval 3.4 to 17.6	16.8 months Interval 12.6 to 20.4	16.8 months Interval 12.6 to 20.4

SECONDARY outcome

Timeframe: up to 85 months of follow-up

Population: Subjects that received at least 2 cycles of treatment

Overall survival time, in months, is calculated from the date of treatment to date of death, and to date of last follow-up for those still alive.

Outcome measures

Outcome measures
Measure	Arm A n=13 Participants Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression after 2 cycles of treatment may crossover to arm B.	Arm B n=23 Participants Patients receive oral sorafenib twice daily on days 2-19. Patients also receive carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.	Arm C: Crossover From Arm A to B n=5 Participants Cross-over arm: Patients receive oral sorafenib twice daily on days 2-19. Patients also receive carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Overall Survival	25.6 months Interval 16.2 to 68.3	25.9 months Interval 15.4 to 42.1	25.9 months Interval 15.4 to 42.1

Adverse Events

Arm A

Serious events: 3 serious events

Other events: 13 other events

Deaths: 0 deaths

Arm B

Serious events: 5 serious events

Other events: 29 other events

Deaths: 0 deaths

Arm C

Serious events: 2 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Steven Waggoner, MD

University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Phone: 216-844-5011

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60

Measure	Arm A n=13 participants at risk；n=14 participants at risk Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression crossover to arm II	Arm B n=29 participants at risk；n=30 participants at risk Patients receive oral sorafenib twice daily on days 2-19. Patients also receive carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.	Arm C n=5 participants at risk Patients from Arm A that had progressive disease were eligible to crossover to Arm B
Immune system disorders Allergic reaction/hypersensitivity (including drug fever)	0.00% 0/14 • Adverse events collected during treatment for all patients over a 7 year period from 2004-2011. Serious Adverse Event and Adverse Event data reported on Arm A includes events from Arm C patients while on Arm A.	3.3% 1/30 • Number of events 1 • Adverse events collected during treatment for all patients over a 7 year period from 2004-2011. Serious Adverse Event and Adverse Event data reported on Arm A includes events from Arm C patients while on Arm A.	20.0% 1/5 • Number of events 1 • Adverse events collected during treatment for all patients over a 7 year period from 2004-2011. Serious Adverse Event and Adverse Event data reported on Arm A includes events from Arm C patients while on Arm A.
Gastrointestinal disorders Bowel obstruction	0.00% 0/14 • Adverse events collected during treatment for all patients over a 7 year period from 2004-2011. Serious Adverse Event and Adverse Event data reported on Arm A includes events from Arm C patients while on Arm A.	0.00% 0/30 • Adverse events collected during treatment for all patients over a 7 year period from 2004-2011. Serious Adverse Event and Adverse Event data reported on Arm A includes events from Arm C patients while on Arm A.	20.0% 1/5 • Number of events 1 • Adverse events collected during treatment for all patients over a 7 year period from 2004-2011. Serious Adverse Event and Adverse Event data reported on Arm A includes events from Arm C patients while on Arm A.
Gastrointestinal disorders Diarrhea	7.1% 1/14 • Number of events 1 • Adverse events collected during treatment for all patients over a 7 year period from 2004-2011. Serious Adverse Event and Adverse Event data reported on Arm A includes events from Arm C patients while on Arm A.	0.00% 0/30 • Adverse events collected during treatment for all patients over a 7 year period from 2004-2011. Serious Adverse Event and Adverse Event data reported on Arm A includes events from Arm C patients while on Arm A.	0.00% 0/5 • Adverse events collected during treatment for all patients over a 7 year period from 2004-2011. Serious Adverse Event and Adverse Event data reported on Arm A includes events from Arm C patients while on Arm A.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/14 • Adverse events collected during treatment for all patients over a 7 year period from 2004-2011. Serious Adverse Event and Adverse Event data reported on Arm A includes events from Arm C patients while on Arm A.	6.7% 2/30 • Number of events 2 • Adverse events collected during treatment for all patients over a 7 year period from 2004-2011. Serious Adverse Event and Adverse Event data reported on Arm A includes events from Arm C patients while on Arm A.	0.00% 0/5 • Adverse events collected during treatment for all patients over a 7 year period from 2004-2011. Serious Adverse Event and Adverse Event data reported on Arm A includes events from Arm C patients while on Arm A.
General disorders Fever (in the absence of neutropenia, where neutropenia is defined as AGC<1.0 x 10e9/L)	7.1% 1/14 • Number of events 1 • Adverse events collected during treatment for all patients over a 7 year period from 2004-2011. Serious Adverse Event and Adverse Event data reported on Arm A includes events from Arm C patients while on Arm A.	3.3% 1/30 • Number of events 1 • Adverse events collected during treatment for all patients over a 7 year period from 2004-2011. Serious Adverse Event and Adverse Event data reported on Arm A includes events from Arm C patients while on Arm A.	0.00% 0/5 • Adverse events collected during treatment for all patients over a 7 year period from 2004-2011. Serious Adverse Event and Adverse Event data reported on Arm A includes events from Arm C patients while on Arm A.
Injury, poisoning and procedural complications Fracture/Right Shoulder	0.00% 0/14 • Adverse events collected during treatment for all patients over a 7 year period from 2004-2011. Serious Adverse Event and Adverse Event data reported on Arm A includes events from Arm C patients while on Arm A.	3.3% 1/30 • Number of events 1 • Adverse events collected during treatment for all patients over a 7 year period from 2004-2011. Serious Adverse Event and Adverse Event data reported on Arm A includes events from Arm C patients while on Arm A.	0.00% 0/5 • Adverse events collected during treatment for all patients over a 7 year period from 2004-2011. Serious Adverse Event and Adverse Event data reported on Arm A includes events from Arm C patients while on Arm A.
Metabolism and nutrition disorders Hypokalemia	7.1% 1/14 • Number of events 1 • Adverse events collected during treatment for all patients over a 7 year period from 2004-2011. Serious Adverse Event and Adverse Event data reported on Arm A includes events from Arm C patients while on Arm A.	0.00% 0/30 • Adverse events collected during treatment for all patients over a 7 year period from 2004-2011. Serious Adverse Event and Adverse Event data reported on Arm A includes events from Arm C patients while on Arm A.	0.00% 0/5 • Adverse events collected during treatment for all patients over a 7 year period from 2004-2011. Serious Adverse Event and Adverse Event data reported on Arm A includes events from Arm C patients while on Arm A.
Metabolism and nutrition disorders Hyponatremia	7.1% 1/14 • Number of events 1 • Adverse events collected during treatment for all patients over a 7 year period from 2004-2011. Serious Adverse Event and Adverse Event data reported on Arm A includes events from Arm C patients while on Arm A.	0.00% 0/30 • Adverse events collected during treatment for all patients over a 7 year period from 2004-2011. Serious Adverse Event and Adverse Event data reported on Arm A includes events from Arm C patients while on Arm A.	0.00% 0/5 • Adverse events collected during treatment for all patients over a 7 year period from 2004-2011. Serious Adverse Event and Adverse Event data reported on Arm A includes events from Arm C patients while on Arm A.
Skin and subcutaneous tissue disorders Keratosis on left lateral forearm	7.1% 1/14 • Number of events 1 • Adverse events collected during treatment for all patients over a 7 year period from 2004-2011. Serious Adverse Event and Adverse Event data reported on Arm A includes events from Arm C patients while on Arm A.	0.00% 0/30 • Adverse events collected during treatment for all patients over a 7 year period from 2004-2011. Serious Adverse Event and Adverse Event data reported on Arm A includes events from Arm C patients while on Arm A.	0.00% 0/5 • Adverse events collected during treatment for all patients over a 7 year period from 2004-2011. Serious Adverse Event and Adverse Event data reported on Arm A includes events from Arm C patients while on Arm A.
Gastrointestinal disorders Nausea	7.1% 1/14 • Number of events 1 • Adverse events collected during treatment for all patients over a 7 year period from 2004-2011. Serious Adverse Event and Adverse Event data reported on Arm A includes events from Arm C patients while on Arm A.	0.00% 0/30 • Adverse events collected during treatment for all patients over a 7 year period from 2004-2011. Serious Adverse Event and Adverse Event data reported on Arm A includes events from Arm C patients while on Arm A.	0.00% 0/5 • Adverse events collected during treatment for all patients over a 7 year period from 2004-2011. Serious Adverse Event and Adverse Event data reported on Arm A includes events from Arm C patients while on Arm A.
Nervous system disorders Pain- Headache	7.1% 1/14 • Number of events 1 • Adverse events collected during treatment for all patients over a 7 year period from 2004-2011. Serious Adverse Event and Adverse Event data reported on Arm A includes events from Arm C patients while on Arm A.	0.00% 0/30 • Adverse events collected during treatment for all patients over a 7 year period from 2004-2011. Serious Adverse Event and Adverse Event data reported on Arm A includes events from Arm C patients while on Arm A.	0.00% 0/5 • Adverse events collected during treatment for all patients over a 7 year period from 2004-2011. Serious Adverse Event and Adverse Event data reported on Arm A includes events from Arm C patients while on Arm A.
Respiratory, thoracic and mediastinal disorders Pleural effusion (non-malignant)	7.1% 1/14 • Number of events 1 • Adverse events collected during treatment for all patients over a 7 year period from 2004-2011. Serious Adverse Event and Adverse Event data reported on Arm A includes events from Arm C patients while on Arm A.	0.00% 0/30 • Adverse events collected during treatment for all patients over a 7 year period from 2004-2011. Serious Adverse Event and Adverse Event data reported on Arm A includes events from Arm C patients while on Arm A.	0.00% 0/5 • Adverse events collected during treatment for all patients over a 7 year period from 2004-2011. Serious Adverse Event and Adverse Event data reported on Arm A includes events from Arm C patients while on Arm A.
Skin and subcutaneous tissue disorders Rash/desquamation	7.1% 1/14 • Number of events 1 • Adverse events collected during treatment for all patients over a 7 year period from 2004-2011. Serious Adverse Event and Adverse Event data reported on Arm A includes events from Arm C patients while on Arm A.	3.3% 1/30 • Number of events 1 • Adverse events collected during treatment for all patients over a 7 year period from 2004-2011. Serious Adverse Event and Adverse Event data reported on Arm A includes events from Arm C patients while on Arm A.	0.00% 0/5 • Adverse events collected during treatment for all patients over a 7 year period from 2004-2011. Serious Adverse Event and Adverse Event data reported on Arm A includes events from Arm C patients while on Arm A.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Secondary Malignancy-Other, excludes metastasis from initial primary	14.3% 2/14 • Number of events 2 • Adverse events collected during treatment for all patients over a 7 year period from 2004-2011. Serious Adverse Event and Adverse Event data reported on Arm A includes events from Arm C patients while on Arm A.	0.00% 0/30 • Adverse events collected during treatment for all patients over a 7 year period from 2004-2011. Serious Adverse Event and Adverse Event data reported on Arm A includes events from Arm C patients while on Arm A.	0.00% 0/5 • Adverse events collected during treatment for all patients over a 7 year period from 2004-2011. Serious Adverse Event and Adverse Event data reported on Arm A includes events from Arm C patients while on Arm A.
Nervous system disorders Syncope	0.00% 0/14 • Adverse events collected during treatment for all patients over a 7 year period from 2004-2011. Serious Adverse Event and Adverse Event data reported on Arm A includes events from Arm C patients while on Arm A.	3.3% 1/30 • Number of events 1 • Adverse events collected during treatment for all patients over a 7 year period from 2004-2011. Serious Adverse Event and Adverse Event data reported on Arm A includes events from Arm C patients while on Arm A.	0.00% 0/5 • Adverse events collected during treatment for all patients over a 7 year period from 2004-2011. Serious Adverse Event and Adverse Event data reported on Arm A includes events from Arm C patients while on Arm A.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/14 • Adverse events collected during treatment for all patients over a 7 year period from 2004-2011. Serious Adverse Event and Adverse Event data reported on Arm A includes events from Arm C patients while on Arm A.	3.3% 1/30 • Number of events 1 • Adverse events collected during treatment for all patients over a 7 year period from 2004-2011. Serious Adverse Event and Adverse Event data reported on Arm A includes events from Arm C patients while on Arm A.	0.00% 0/5 • Adverse events collected during treatment for all patients over a 7 year period from 2004-2011. Serious Adverse Event and Adverse Event data reported on Arm A includes events from Arm C patients while on Arm A.
Gastrointestinal disorders Vomiting	0.00% 0/14 • Adverse events collected during treatment for all patients over a 7 year period from 2004-2011. Serious Adverse Event and Adverse Event data reported on Arm A includes events from Arm C patients while on Arm A.	0.00% 0/30 • Adverse events collected during treatment for all patients over a 7 year period from 2004-2011. Serious Adverse Event and Adverse Event data reported on Arm A includes events from Arm C patients while on Arm A.	20.0% 1/5 • Number of events 1 • Adverse events collected during treatment for all patients over a 7 year period from 2004-2011. Serious Adverse Event and Adverse Event data reported on Arm A includes events from Arm C patients while on Arm A.
Investigations White blood cell decreased/Neutropenia	0.00% 0/14 • Adverse events collected during treatment for all patients over a 7 year period from 2004-2011. Serious Adverse Event and Adverse Event data reported on Arm A includes events from Arm C patients while on Arm A.	6.7% 2/30 • Number of events 2 • Adverse events collected during treatment for all patients over a 7 year period from 2004-2011. Serious Adverse Event and Adverse Event data reported on Arm A includes events from Arm C patients while on Arm A.	0.00% 0/5 • Adverse events collected during treatment for all patients over a 7 year period from 2004-2011. Serious Adverse Event and Adverse Event data reported on Arm A includes events from Arm C patients while on Arm A.