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Paclitaxel and Carboplatin With Or Without Sorafenib In The First-Line Treatment Of Patients With Ovarian Cancer

A Randomized Phase II Study of Paclitaxel/Carboplatin With or Without Sorafenib in the First-Line Treatment of Patients With Stage III/IV Epithelial Ovarian Cancer

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00390611
Enrollment
85
Registered
2006-10-20
Start date
2006-10-31
Completion date
2014-04-30
Last updated
2014-12-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovarian Cancer

Keywords

Ovarian Cancer

Brief summary

This trial will compare the efficacy and toxicity of standard first-line chemotherapy alone vs. standard chemotherapy plus sorafenib in patients with stage III/IV ovarian cancer following cytoreductive surgery. Patients with residual large volume disease and/or bowel involvement will be excluded, to minimize the risk of bowel perforation.

Detailed description

All patients must be at least 4 weeks from cytoreductive surgery before starting treatment. Patients will be randomized to receive treatment with either paclitaxel/carboplatin + sorafenib or paclitaxel/carboplatin. Paclitaxel/carboplatin will be repeated every 21 days for a maximum of 6 cycles. Patients with objective response/stable disease after completing 6 courses of chemotherapy will continue sorafenib until disease progression or for a total of 12 months. \- Regimen A: Paclitaxel 175 mg/m2 1-3 hour IV infusion, Day 1 Carboplatin AUC 6 infused over 20 minutes IV, Day 1 Sorafenib 400mg PO bid \- Regimen B: Paclitaxel 175mg/m2, 1-3 hour IV infusion, Day 1 Carboplatin AUC 6.0, 20 minute IV infusion, Day 1

Interventions

DRUGSorafenib
DRUGPaclitaxel

Paclitaxel

DRUGCarboplatin

Carboplatin

Sponsors

Bayer
CollaboratorINDUSTRY
SCRI Development Innovations, LLC
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Histologically confirmed, stage III or IV epithelial ovarian carcinoma 2. No previous treatment with chemotherapy or radiation therapy 3. All patients must have undergone cytoreductive surgery, with the following results: 1. No residual tumor nodule \> 3cm 2. No residual tumor involvement of the bowel (ie. invasion into bowel wall) 3. No residual intestinal obstruction 4. Measurable or evaluable disease. Patients with elevated CA-125 levels and/or evaluable disease per RECIST criteria are eligible. 5. ECOG performance status 0 or 1. 6. ANC ≥ 1500/µL, platelets ≥ 100,000/µL, hemoglobin ≥ 9.0 g/dL. 7. Total bilirubin ≤ 1.5 x upper limits of normal (ULN), ALT and AST ≤ 2.5 x ULN (≤ 5 x ULN for patients with liver metastases) 8. Serum creatinine \_ 1.5 x ULN 9. INR \< 1.5 or a PT/PTT within normal limits. Patients receiving anticoagulation treatment with an agent such as warfarin or heparin may be allowed to participate. For patients on warfarin, the INR may be \> 1.5, and should be measured prior to initiation of sorafenib and monitored at least weekly until INR is stable in the desired therapeutic range. 10. Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to start of treatment. 11. Patients must be able to understand the nature of this study and give written informed consent.

Exclusion criteria

1. Age \< 18 years 2. Active cardiac disease, including: A) congestive heart failure \> class II NYHA , B) unstable angina or onset of angina within last 3 months, C) myocardial infarction within 6 months 3. Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy 4. Patients with CNS metastases. Patients with neurological symptoms must undergo a CT scan/MRI of the brain to exclude brain metastasis. 5. Uncontrolled hypertension defined as systolic blood pressure \> 150mmHg or diastolic pressure \> 90mmHg, despite optimal medical management 6. Known HIV, chronic hepatitis B or chronic hepatitis C infections 7. Women who are pregnant or lactating. Women of childbearing potential must agree to use adequate contraception from time of study entry until at least 3 months after the last administration of study drug. 8. Active clinically serious infection (\> grade 2) 9. Thrombotic or embolic events such as cerebral vascular accident including transient ischemic attacks within the last 6 months. 10. Pulmonary hemorrhage/bleeding event ≥ grade 2 within 4 weeks of starting treatment. 11. Any other hemorrhage/bleeding event ≥ grade 3 within 4 weeks of starting treatment 12. Serious non-healing wound, ulcer, or bone fracture 13. Evidence of history of bleeding diathesis or coagulopathy 14. Major surgery, open biopsy, or significant traumatic injury within 4 weeks of starting treatment. 15. Any condition that impairs the ability to swallow whole pills 16. Patients with any type of malabsorption 17. Known or suspected allergy to any of the agents used in this treatment 18. Use of St. John's Wort or rifampin

Design outcomes

Primary

MeasureTime frameDescription
2-year Progression-free Survival2 yearsThe proportion of patients with progression-free survival at 2 years. Progression-free survival is measured from Day 1 of study drug administration to disease progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death on study. Progression is defined in RECIST v1.1 as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions

Secondary

MeasureTime frameDescription
Overall Response Rate (ORR)18 monthsNumber of patients with either complete response (CR) or partial response (PR) as defined in Response Evaluation Criteria in Solid Tumors (for patients with measurable disease) or determined by CA-125 levels (for patients without measurable disease). Complete Response: Disappearance of all target lesions, disappearance of all non-target lesions, and normalization of CA-125 for at least 4 weeks. In patients who have only elevated CA-125, the CA-125 must normalize (\< 23U/mL) for more than 4 weeks. Partial Response: At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameters. For patients with elevated CA-125 only, partial response will be defined as a \> 50% decrease in the serum CA-125 level.
Overall Survival (OS)18 monthsOverall survival was measured from the date of study entry until the date of death
Toxicity of Paclitaxel/Carboplatin vs. Paclitaxel/Carboplatin/Sorafenib18 monthsNumber of patients experiencing treatment-related adverse events

Countries

United States

Participant flow

Participants by arm

ArmCount
Paclitaxel/Carboplatin/Sorafenib
Paclitaxel 175 mg/m2 1-3 hour IV infusion, Day 1 Carboplatin AUC 6 infused over 20 minutes IV, Day 1 Sorafenib 400mg PO bid Sorafenib Paclitaxel: Paclitaxel Carboplatin: Carboplatin
43
Paclitaxel/Carboplatin
Paclitaxel 175 mg/m2 1-3 hour IV infusion, Day 1 Carboplatin AUC 6 infused over 20 minutes IV Paclitaxel: Paclitaxel Carboplatin: Carboplatin
42
Total85

Baseline characteristics

CharacteristicPaclitaxel/Carboplatin/SorafenibPaclitaxel/CarboplatinTotal
Age, Continuous63 years62 years62 years
Region of Enrollment
United States
43 participants42 participants85 participants
Sex: Female, Male
Female
43 Participants42 Participants85 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
43 / 4342 / 42
serious
Total, serious adverse events
12 / 4310 / 42

Outcome results

Primary

2-year Progression-free Survival

The proportion of patients with progression-free survival at 2 years. Progression-free survival is measured from Day 1 of study drug administration to disease progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death on study. Progression is defined in RECIST v1.1 as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions

Time frame: 2 years

ArmMeasureValue (NUMBER)
Paclitaxel/Carboplatin/Sorafenib2-year Progression-free Survival40 percentage of participants
Paclitaxel/Carboplatin2-year Progression-free Survival40 percentage of participants
Secondary

Overall Response Rate (ORR)

Number of patients with either complete response (CR) or partial response (PR) as defined in Response Evaluation Criteria in Solid Tumors (for patients with measurable disease) or determined by CA-125 levels (for patients without measurable disease). Complete Response: Disappearance of all target lesions, disappearance of all non-target lesions, and normalization of CA-125 for at least 4 weeks. In patients who have only elevated CA-125, the CA-125 must normalize (\< 23U/mL) for more than 4 weeks. Partial Response: At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameters. For patients with elevated CA-125 only, partial response will be defined as a \> 50% decrease in the serum CA-125 level.

Time frame: 18 months

ArmMeasureValue (NUMBER)
Paclitaxel/Carboplatin/SorafenibOverall Response Rate (ORR)29 participants
Paclitaxel/CarboplatinOverall Response Rate (ORR)31 participants
Secondary

Overall Survival (OS)

Overall survival was measured from the date of study entry until the date of death

Time frame: 18 months

ArmMeasureValue (MEDIAN)
Paclitaxel/Carboplatin/SorafenibOverall Survival (OS)36.5 months
Paclitaxel/CarboplatinOverall Survival (OS)NA months
Secondary

Toxicity of Paclitaxel/Carboplatin vs. Paclitaxel/Carboplatin/Sorafenib

Number of patients experiencing treatment-related adverse events

Time frame: 18 months

ArmMeasureGroupValue (NUMBER)
Paclitaxel/Carboplatin/SorafenibToxicity of Paclitaxel/Carboplatin vs. Paclitaxel/Carboplatin/SorafenibMucositis16 participants
Paclitaxel/Carboplatin/SorafenibToxicity of Paclitaxel/Carboplatin vs. Paclitaxel/Carboplatin/SorafenibPain-joint9 participants
Paclitaxel/Carboplatin/SorafenibToxicity of Paclitaxel/Carboplatin vs. Paclitaxel/Carboplatin/SorafenibConstipation7 participants
Paclitaxel/Carboplatin/SorafenibToxicity of Paclitaxel/Carboplatin vs. Paclitaxel/Carboplatin/SorafenibAnorexia9 participants
Paclitaxel/Carboplatin/SorafenibToxicity of Paclitaxel/Carboplatin vs. Paclitaxel/Carboplatin/SorafenibThrombocytopenia26 participants
Paclitaxel/Carboplatin/SorafenibToxicity of Paclitaxel/Carboplatin vs. Paclitaxel/Carboplatin/SorafenibHand-foot syndrome16 participants
Paclitaxel/Carboplatin/SorafenibToxicity of Paclitaxel/Carboplatin vs. Paclitaxel/Carboplatin/SorafenibPain-muscle12 participants
Paclitaxel/Carboplatin/SorafenibToxicity of Paclitaxel/Carboplatin vs. Paclitaxel/Carboplatin/SorafenibAbdominal pain9 participants
Paclitaxel/Carboplatin/SorafenibToxicity of Paclitaxel/Carboplatin vs. Paclitaxel/Carboplatin/SorafenibFebrile neutropenia3 participants
Paclitaxel/Carboplatin/SorafenibToxicity of Paclitaxel/Carboplatin vs. Paclitaxel/Carboplatin/SorafenibWeakness7 participants
Paclitaxel/Carboplatin/SorafenibToxicity of Paclitaxel/Carboplatin vs. Paclitaxel/Carboplatin/SorafenibDiarrhea22 participants
Paclitaxel/Carboplatin/SorafenibToxicity of Paclitaxel/Carboplatin vs. Paclitaxel/Carboplatin/SorafenibHypertension10 participants
Paclitaxel/Carboplatin/SorafenibToxicity of Paclitaxel/Carboplatin vs. Paclitaxel/Carboplatin/SorafenibNausea/vomiting33 participants
Paclitaxel/Carboplatin/SorafenibToxicity of Paclitaxel/Carboplatin vs. Paclitaxel/Carboplatin/SorafenibDizziness6 participants
Paclitaxel/Carboplatin/SorafenibToxicity of Paclitaxel/Carboplatin vs. Paclitaxel/Carboplatin/SorafenibPruritus3 participants
Paclitaxel/Carboplatin/SorafenibToxicity of Paclitaxel/Carboplatin vs. Paclitaxel/Carboplatin/SorafenibFever (no neutropenia)6 participants
Paclitaxel/Carboplatin/SorafenibToxicity of Paclitaxel/Carboplatin vs. Paclitaxel/Carboplatin/SorafenibPeripheral neuropathy31 participants
Paclitaxel/Carboplatin/SorafenibToxicity of Paclitaxel/Carboplatin vs. Paclitaxel/Carboplatin/SorafenibDehydration5 participants
Paclitaxel/Carboplatin/SorafenibToxicity of Paclitaxel/Carboplatin vs. Paclitaxel/Carboplatin/SorafenibNeutropenia28 participants
Paclitaxel/Carboplatin/SorafenibToxicity of Paclitaxel/Carboplatin vs. Paclitaxel/Carboplatin/SorafenibDyspnea3 participants
Paclitaxel/Carboplatin/SorafenibToxicity of Paclitaxel/Carboplatin vs. Paclitaxel/Carboplatin/SorafenibFatigue29 participants
Paclitaxel/Carboplatin/SorafenibToxicity of Paclitaxel/Carboplatin vs. Paclitaxel/Carboplatin/SorafenibHeadache5 participants
Paclitaxel/Carboplatin/SorafenibToxicity of Paclitaxel/Carboplatin vs. Paclitaxel/Carboplatin/SorafenibHypersensitivity reaction (paclitaxel)6 participants
Paclitaxel/Carboplatin/SorafenibToxicity of Paclitaxel/Carboplatin vs. Paclitaxel/Carboplatin/SorafenibEdema3 participants
Paclitaxel/Carboplatin/SorafenibToxicity of Paclitaxel/Carboplatin vs. Paclitaxel/Carboplatin/SorafenibSkin rash41 participants
Paclitaxel/Carboplatin/SorafenibToxicity of Paclitaxel/Carboplatin vs. Paclitaxel/Carboplatin/SorafenibHyponatremia4 participants
Paclitaxel/Carboplatin/SorafenibToxicity of Paclitaxel/Carboplatin vs. Paclitaxel/Carboplatin/SorafenibAnemia29 participants
Paclitaxel/CarboplatinToxicity of Paclitaxel/Carboplatin vs. Paclitaxel/Carboplatin/SorafenibPruritus1 participants
Paclitaxel/CarboplatinToxicity of Paclitaxel/Carboplatin vs. Paclitaxel/Carboplatin/SorafenibSkin rash3 participants
Paclitaxel/CarboplatinToxicity of Paclitaxel/Carboplatin vs. Paclitaxel/Carboplatin/SorafenibDiarrhea8 participants
Paclitaxel/CarboplatinToxicity of Paclitaxel/Carboplatin vs. Paclitaxel/Carboplatin/SorafenibPain-muscle14 participants
Paclitaxel/CarboplatinToxicity of Paclitaxel/Carboplatin vs. Paclitaxel/Carboplatin/SorafenibPain-joint11 participants
Paclitaxel/CarboplatinToxicity of Paclitaxel/Carboplatin vs. Paclitaxel/Carboplatin/SorafenibHyponatremia0 participants
Paclitaxel/CarboplatinToxicity of Paclitaxel/Carboplatin vs. Paclitaxel/Carboplatin/SorafenibNeutropenia33 participants
Paclitaxel/CarboplatinToxicity of Paclitaxel/Carboplatin vs. Paclitaxel/Carboplatin/SorafenibAnemia30 participants
Paclitaxel/CarboplatinToxicity of Paclitaxel/Carboplatin vs. Paclitaxel/Carboplatin/SorafenibThrombocytopenia25 participants
Paclitaxel/CarboplatinToxicity of Paclitaxel/Carboplatin vs. Paclitaxel/Carboplatin/SorafenibFebrile neutropenia1 participants
Paclitaxel/CarboplatinToxicity of Paclitaxel/Carboplatin vs. Paclitaxel/Carboplatin/SorafenibNausea/vomiting37 participants
Paclitaxel/CarboplatinToxicity of Paclitaxel/Carboplatin vs. Paclitaxel/Carboplatin/SorafenibPeripheral neuropathy28 participants
Paclitaxel/CarboplatinToxicity of Paclitaxel/Carboplatin vs. Paclitaxel/Carboplatin/SorafenibFatigue32 participants
Paclitaxel/CarboplatinToxicity of Paclitaxel/Carboplatin vs. Paclitaxel/Carboplatin/SorafenibHypersensitivity reaction (paclitaxel)1 participants
Paclitaxel/CarboplatinToxicity of Paclitaxel/Carboplatin vs. Paclitaxel/Carboplatin/SorafenibMucositis7 participants
Paclitaxel/CarboplatinToxicity of Paclitaxel/Carboplatin vs. Paclitaxel/Carboplatin/SorafenibAnorexia8 participants
Paclitaxel/CarboplatinToxicity of Paclitaxel/Carboplatin vs. Paclitaxel/Carboplatin/SorafenibHand-foot syndrome0 participants
Paclitaxel/CarboplatinToxicity of Paclitaxel/Carboplatin vs. Paclitaxel/Carboplatin/SorafenibAbdominal pain5 participants
Paclitaxel/CarboplatinToxicity of Paclitaxel/Carboplatin vs. Paclitaxel/Carboplatin/SorafenibWeakness6 participants
Paclitaxel/CarboplatinToxicity of Paclitaxel/Carboplatin vs. Paclitaxel/Carboplatin/SorafenibHypertension2 participants
Paclitaxel/CarboplatinToxicity of Paclitaxel/Carboplatin vs. Paclitaxel/Carboplatin/SorafenibDizziness6 participants
Paclitaxel/CarboplatinToxicity of Paclitaxel/Carboplatin vs. Paclitaxel/Carboplatin/SorafenibFever (no neutropenia)5 participants
Paclitaxel/CarboplatinToxicity of Paclitaxel/Carboplatin vs. Paclitaxel/Carboplatin/SorafenibDehydration4 participants
Paclitaxel/CarboplatinToxicity of Paclitaxel/Carboplatin vs. Paclitaxel/Carboplatin/SorafenibDyspnea5 participants
Paclitaxel/CarboplatinToxicity of Paclitaxel/Carboplatin vs. Paclitaxel/Carboplatin/SorafenibHeadache3 participants
Paclitaxel/CarboplatinToxicity of Paclitaxel/Carboplatin vs. Paclitaxel/Carboplatin/SorafenibEdema2 participants
Paclitaxel/CarboplatinToxicity of Paclitaxel/Carboplatin vs. Paclitaxel/Carboplatin/SorafenibConstipation14 participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026