Clinical trial · Interventional
Sorafenib in Treating Patients With Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Peritoneal Cancer in at Least the Second Remission
A Phase II Trial of Oral Sorafenib (Bay43-9006) In Women With Epithelial Ovarian, Fallopian Tube Or Peritoneal Carcinoma In Second Or Greater Remission
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. PURPOSE: This phase II trial is studying how well sorafenib works in treating patients with ovarian epithelial cancer, fallopian tube cancer, or peritoneal cancer in at least the second remission.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Fallopian Tube Cancer | Malignant Fallopian Tube Neoplasm | ALIAS | 0.90 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Primary Peritoneal Cavity Cancer | — | UNRESOLVED | — |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| immunoenzyme technique | Other | — | UNRESOLVED |
| immunohistochemistry staining method | Other | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| pharmacological study | Other | — | UNRESOLVED |
| sorafenib tosylate | Drug | Sorafenib Tosylate | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Oral Sorafenib (BAY43-9006)
- description
- Sorafenib is supplied as 200-mg tablets. Sorafenib will be administered as 400 mg orally daily x 28 days (continuous). One cycle = 28 days. There is no planned treatment interruption between cycles. Sorafenib should be taken without food (at least 1 hour before or 2 hours after eating). In the absence of intolerable toxicity, a patient may continue to receive treatment with sorafenib until disease progression, or until 24 months have elapsed.
- interventionNames
- Drug: sorafenib tosylate
- Other: immunoenzyme technique
- Other: immunohistochemistry staining method
- Other: laboratory biomarker analysis
- Other: pharmacological study
Primary outcomes (1)
- measure
- Progression-free Survival (PFS) Rate at 12 Months
- timeFrame
- 1 year
- description
- All 5 patients experienced a rash. As a result, all 5 were either advised to withdraw from the protocol, or withdrew themselves from the protocol. The outcome was not met.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed epithelial carcinoma arising in the ovary, fallopian tube, or peritoneum
* Any stage and grade at diagnosis
* Must have received initial cytoreductive surgery and chemotherapy with ≥ 1 platinum-based chemotherapy regimen
* Persistent or recurrent disease after initial therapy
* In complete clinical remission after chemotherapy for recurrent disease, meeting all of the following criteria:
* CA125 ≤ 35 units/L
* Normal physical examination
* No definite evidence of disease by CT scan of the abdomen and pelvis
* Lymph nodes and/or soft tissue abnormalities ≤ 1.0 cm are not considered definite evidence of disease
* No known brain metastases
PATIENT CHARACTERISTICS:
Inclusion criteria:
* Karnofsky performance status 70-100%
* Life expectancy \> 3 months
* ANC ≥ 1,500/mm³
* Platelet count ≥ 100,000/mm³
* Hemoglobin ≥ 9.0 g/dL
* INR \< 1.5 OR PT/PTT within normal limits
* Creatinine ≤ 1.5 times upper limit of normal (ULN)
* Urinalysis negative for protein
* If urinalysis shows 1+ protein by dipstick or protein ≥ 30-100 mg/dL by semi-quantitative assay, a 24-hour urine collection is required
* Eligible patients must have a total urinary protein ≤ 500 mg AND measured creatinine clearance ≥ 50 mL/min from a 24-hour urine collection
* Bilirubin ≤ 1.5 times ULN
* AST and ALT ≤ 2.5 times ULN
* Alkaline phosphatase ≤ 2.5 times ULN
* Stable blood pressure (BP) measurement required on 3 separate days prior to the start of treatment
* No peripheral neuropathy \> grade 1
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
Exclusion criteria:
* Other invasive malignancies within the past 5 years, except nonmelanoma skin cancer
* Uncontrolled concurrent illness or medical condition including, but not limited to, any of the following:
* Ongoing or active infection
* Symptomatic congestive heart failure
* Unstable angina pectoris
* Cardiac arrhythmia
* Uncontrolled diabetes
* Psychiatric illness or social situation that would preclude study compliance
* Uncontrolled hypertension defined as a persistent BP \> 150/100 mm Hg (or a persistent BP \> 180/90 mm Hg if the patient has a history of isolated systolic hypertension) despite ≥ 2 attempts at antihypertensive medication dosage adjustment ≥ 2 weeks apart
* Thrombolic or embolic events such as cerebrovascular accident, including transient ischemic attack, within the past 6 months
* Pulmonary hemorrhage or bleeding event ≥ grade 2 within 4 weeks of the first dose of study drug
* Other hemorrhage or bleeding event ≥ grade 3 within 4 weeks of the first dose of study drug
* Serious nonhealing wound, ulcer, or bone fracture
* Evidence or history of bleeding diathesis or coagulopathy
* Inability to take oral medications or gastrointestinal condition that compromises absorption
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to sorafenib tosylate
PRIOR CONCURRENT THERAPY:
Inclusion criteria:
* See Disease Characteristics
* No prior sorafenib tosylate or other inhibitors of MAPK signaling intermediates or angiogenesis inhibitors
* No prior cancer treatment that would contraindicate protocol therapy
* More than 4 weeks since prior radiotherapy
* More than 3 weeks since prior chemotherapy, biological therapy, or immunotherapy
* More than 1 week since prior hormonal therapy for cancer treatment
Exclusion criteria:
* Major surgery (i.e., laparotomy) within the past 4 weeks or minor surgery within the past 2 weeks
* Placement of a vascular access device is not considered minor surgery
* Concurrent combination antiretroviral therapy for HIV-positive patients
* Concurrent St. John wort, rifampin, or enzyme-inducing anticonvulsants (e.g., carbamazepine, phenytoin, or phenobarbital)References
Publications (0)
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