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CompletedNCT00096200Updated Feb 8, 2022Results posted

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

A Phase 2 interventional study of Carboplatin and Paclitaxel in Recurrent Fallopian Tube Carcinoma, Recurrent Ovarian Carcinoma and Recurrent Primary Peritoneal Carcinoma, sponsored by National Cancer Institute (NCI). Completed at 5 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-02-08.

Sponsored by National Cancer Institute (NCI) · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
44
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study summary

Sorafenib may stop the growth of tumor cells by blocking the enzymes necessary for their growth and by stopping blood flow to the tumor. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving sorafenib together with chemotherapy may kill more tumor cells. This randomized phase II trial is studying how well giving sorafenib together with paclitaxel and carboplatin works in treating patients with recurrent ovarian cancer, primary peritoneal cancer, or fallopian tube cancer. (Sorafenib only group closed as of 10/10/2008).

Read the detailed description

PRIMARY OBJECTIVES :

I. Compare the progression-free and overall survival rate of patients with recurrent platinum-sensitive ovarian epithelial, primary peritoneal, or fallopian tube cancer treated with sorafenib with or without carboplatin and paclitaxel. (Arm I [sorafenib only] closed to accrual 10/01/2008) II. Evaluate the response rate and time to disease progression in patients treated with these regimens.

OUTLINE: This is a multicenter study. Patients are stratified according to performance status and participating center.

ARM I (closed to accrual 10/01/2008): 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 II: 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.

02

Conditions studied

  • Recurrent Fallopian Tube Carcinoma
  • Recurrent Ovarian Carcinoma
  • Recurrent Primary Peritoneal Carcinoma
03

In context

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.

This study's enrollment of 44 is close to the median of 45 across 5,170 interventional studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

National Cancer Institute (NCI) is the lead sponsor of 3,506 studies on the registry; 334 are open to participants now.

Of its 402 completed or terminated interventional studies of FDA-regulated products, 365 (91%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria:

  • Diagnosis of ovarian epithelial, primary peritoneal, or fallopian tube cancer
  • Recurrent disease
  • Must have received a prior platinum-based regimen
  • Platinum-sensitive (treatment-free interval > 6 months)
  • No more than 2 prior chemotherapy regimens
  • Measurable disease
  • At least 1 unidimensionally measurable lesion >= 20 mm by conventional techniques OR >= 10 mm by spiral CT scan
  • Not in a prior irradiation field
  • No known brain metastases
  • Performance status:

    • ECOG 0-2 OR
    • Karnofsky 80-100%
  • Life expectancy:

    • More than 12 weeks
  • Hematopoietic:

    • Absolute neutrophil count >= 1,500/mm3
    • Platelet count >= 100,000/mm3
    • Hemoglobin >= 9 g/dL
    • No bleeding diathesis
  • Hepatic:

    • Bilirubin \< 1.5 times upper limit of normal (ULN)
    • AST or ALT =\< 2 times ULN
  • No history of allergic reaction attributed to compounds of similar chemical or biological composition to sorafenib or other agents used in the study
  • Patients who have had a reaction to a taxane or a platinum and have not yet been rechallenged may undergo a desensitization regimen on study
  • No hypersensitivity to paclitaxel or drugs using the vehicle Cremophor El:
  • Prior hypersensitivity reaction to paclitaxel allowed provided rechallenged successfully
  • Renal:

    • Creatinine \< 2 mg/dL
  • Cardiovascular:

    • Abnormal cardiac conduction (e.g., bundle branch block or heart block) allowed if stable for the past 6 months
    • No symptomatic congestive heart failure
    • No uncontrolled hypertension
    • No cardiac arrhythmia
    • No unstable angina pectoris;
    • No myocardial infarction within the past 6 months
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Adequate intestinal function
  • No concurrent requirements for IV hydration or nutritional support
  • No active or ongoing infection
  • No psychiatric illness or social situation that would preclude study compliance
  • No other concurrent uncontrolled illness
  • No other invasive malignancy with the past 5 years except nonmelanoma skin cancer
  • More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
  • More than 3 weeks since prior hormonal therapy
  • More than 4 weeks since prior radiotherapy and recovered
  • No prior sorafenib
  • No prior anticancer therapy that contraindicates study therapy
  • No concurrent cytochrome P450 enzyme-inducing antiepileptic drugs (phenytoin, carbamazepine, or phenobarbital), rifampin, or Hypericum perforatum (St. John's wort)
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  • No concurrent therapeutic anticoagulation therapy
  • Concurrent prophylactic low-dose warfarin allowed for maintenance of venous or arterial access devices
  • No other concurrent anticancer therapies
  • No other concurrent investigational agents
  • Not pregnant or nursing
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
44 participants (actual)

Study arms

  • Experimental
    Arm I (closed to accrual 10/10/2008)

    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

    Drug: Sorafenib Tosylate

  • Experimental
    Arm II

    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.

    Drug: Carboplatin · Drug: Paclitaxel · Drug: Sorafenib Tosylate

Interventions

  • DrugCarboplatin

    Given IV

    Also known as: Blastocarb, Carboplat, Carboplatin Hexal, Carboplatino, Carbosin, Carbosol, Carbotec, CBDCA, Displata, Ercar, JM-8, Nealorin, Novoplatinum, Paraplat, Paraplatin, Paraplatin AQ, Paraplatine, Platinwas, Ribocarbo

  • DrugPaclitaxel

    Given IV

    Also known as: Anzatax, Asotax, Bristaxol, Praxel, Taxol, Taxol Konzentrat

  • DrugSorafenib Tosylate

    Given orally

    Also known as: BAY 43-9006 Tosylate, BAY 54-9085, Nexavar, sorafenib

06

What researchers measure

Primary outcomes

  1. Complete and Partial Response Rate Using the Response Evaluation Criteria in Solid Tumors (RECIST) Criteria

    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.

    Time frame: after 6 weeks (2 cycles)

Secondary outcomes

  1. Evaluate the Progression-free Survival Rate

    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.

    Time frame: up to 85 months of follow-up

  2. Overall Survival

    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.

    Time frame: up to 85 months of follow-up

07

Results

Posted Dec 13, 2012

Participant flow

Patients accrued from medical clinic from August 2004 through June 2011

Participant flow — Overall Study
MilestoneArm AArm BArm C
Started9305
Completed8235
Not completed170
Withdrew: Adverse event040
Withdrew: Withdrawal by subject120
Withdrew: Ineligible pathology010

Outcome measures

PrimaryComplete and Partial Response Rate Using the Response Evaluation Criteria in Solid Tumors (RECIST) Criteria

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.

Time frame:
after 6 weeks (2 cycles)
Reported as:
Number · participants
Complete and Partial Response Rate Using the Response Evaluation Criteria in Solid Tumors (RECIST) Criteria
participantsArm AArm BArm C: Crossover From Arm A to B
Partial Response2111
Progressive Disease810
Stable Disease374
Complete Response040
SecondaryEvaluate the Progression-free Survival Rate

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.

Time frame:
up to 85 months of follow-up
Reported as:
Median · months
Evaluate the Progression-free Survival Rate
monthsArm AArm BArm C: Crossover From Arm A to B
Evaluate the Progression-free Survival Rate5.6 (3.4 to 17.6)16.8 (12.6 to 20.4)16.8 (12.6 to 20.4)
SecondaryOverall Survival

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.

Time frame:
up to 85 months of follow-up
Reported as:
Median · months
Overall Survival
monthsArm AArm BArm C: Crossover From Arm A to B
Overall Survival25.6 (16.2 to 68.3)25.9 (15.4 to 42.1)25.9 (15.4 to 42.1)

Adverse events

Collected over Adverse events collected during treatment for all patients over a 7 year period from 2004-2011.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Arm A—3/14 (21.4%)13/13 (100%)
Arm B—5/30 (16.7%)29/29 (100%)
Arm C—2/5 (40%)5/5 (100%)
Most frequent serious events
Showing 10 of 18
Most frequent serious events
EventArm AArm BArm C
Allergic reaction/hypersensitivity (including drug fever)Immune system disorders0/141/301/5
Bowel obstructionGastrointestinal disorders0/140/301/5
VomitingGastrointestinal disorders0/140/301/5
Secondary Malignancy-Other, excludes metastasis from initial primaryNeoplasms benign, malignant and unspecified (incl cysts and polyps)2/140/300/5
DiarrheaGastrointestinal disorders1/140/300/5
Fever (in the absence of neutropenia, where neutropenia is defined as AGC<1.0 x 10e9/L)General disorders1/141/300/5
HypokalemiaMetabolism and nutrition disorders1/140/300/5
HyponatremiaMetabolism and nutrition disorders1/140/300/5
Keratosis on left lateral forearmSkin and subcutaneous tissue disorders1/140/300/5
NauseaGastrointestinal disorders1/140/300/5
Most frequent other events
Showing 10 of 90
Most frequent other events
EventArm AArm BArm C
DiarrheaGastrointestinal disorders8/1313/294/5
Rash acneiformSkin and subcutaneous tissue disorders10/1313/291/5
Neutrophil count decreasedInvestigations2/1322/293/5
Palmar-plantar erythrodysesthesia syndromeSkin and subcutaneous tissue disorders7/1322/290/5
Peripheral sensory neuropathyNervous system disorders2/1319/293/5
Platelet count decreasedInvestigations1/1319/293/5
FatigueGeneral disorders8/1318/293/5
White blood cell decreasedInvestigations2/1315/293/5
NauseaGastrointestinal disorders4/1314/292/5
AlopeciaSkin and subcutaneous tissue disorders6/1313/292/5

Baseline characteristics

Age, Customized
Age, Customized(participants)Arm AArm BArm CTotal
Age 40-490202
Age 50-59415019
Age 60-6948517
Age 70-791506
Sex: Female, Male
Sex: Female, Male(Participants)Arm AArm BArm CTotal
Female930544
Male0000
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Arm AArm BArm CTotal
Hispanic or Latino0000
Not Hispanic or Latino822535
Unknown or Not Reported1809
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Arm AArm BArm CTotal
American Indian or Alaska Native0000
Asian0000
Native Hawaiian or Other Pacific Islander0000
Black or African American0000
White924538
More than one race0101
Unknown or Not Reported0505
Region of Enrollment
Region of Enrollment(participants)Arm AArm BArm CTotal
United States930544
08

Study locations

5 sites
  • Moffitt Cancer Center at Tampa General Hospital
    Tampa, Florida 33612, United States
  • Moffitt Cancer Center
    Tampa, Florida 33612, United States
  • Case Western Reserve University
    Cleveland, Ohio 44106, United States
  • Lake University Ireland Cancer Center
    Mentor, Ohio 44060, United States
  • Virginia Commonwealth University/Massey Cancer Center
    Richmond, Virginia 23298, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 8, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00096200
Lead sponsor
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Nov 9, 2004
Start date
Aug 2004
Primary completion
Apr 21, 2011
Completion
Aug 2011
Results posted
Dec 13, 2012
Last update
Feb 8, 2022

Study contacts

Steven Waggoner
principal investigator · Case Comprehensive Cancer Center
View the source record on ClinicalTrials.gov ↗

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