Clinical trial · Interventional
Sorafenib + Topotecan for Platinum-Resistant Recurrent Ovarian Cancer
A Phase I/II Study of Sorafenib in Combination With Topotecan for the Treatment of Platinum-Resistant Recurrent Ovarian Cancer or Primary Peritoneal Carcinomatosis: Hoosier Oncology Group GYN06-111
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study closed to accrual due unfavorable interim analysis
Summary
Brief summary (as posted)
This multi-institutional phase I/II clinical trial will test the tolerability and efficacy of the combination sorafenib and topotecan in patients with recurrent ovarian cancer, which is platinum-resistant (recurrence within 6 months from completing platinum based therapy) or refractory (progressive disease during platinum based therapy).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Phase I
- description
- Topotecan 3.5 mg/m\^2 + Sorafenib dose escalation:
- interventionNames
- Drug: Sorafenib
- Drug: Topotecan
- type
- EXPERIMENTAL
- label
- Phase II
- description
- Topotecan 3.5 mg/m\^2 + Sorafenib 400 mg po daily.
- interventionNames
- Drug: Sorafenib
- Drug: Topotecan
Primary outcomes (2)
- measure
- Maximum Tolerated Dose (MTD)
- timeFrame
- Each participant was treated at their assigned dose level on 28 day cycles until disease progression or unacceptable toxicity. Participants were evaluated for toxicity every two weeks.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Have histologically-confirmed epithelial ovarian cancer, primary peritoneal carcinomatosis or fallopian tube cancer. Enrollment of patients with clear cell histology is encouraged. * Have measurable disease according to RECIST or detectable disease by 1) CA-125 at least twice the ULN within 14 days prior to registration for protocol therapy; 2) Ascites and/or pleural effusion attributed to tumor; 3) solid and/or cystic abnormalities on radiographic imaging that do not meet RECIST definitions for target lesions. * Have failed at least one prior platinum based chemotherapeutic regimen. * No more than 3 prior treatment regimens for epithelial ovarian cancer. * Prior radiation therapy is allowed to \< 25% of the bone marrow. * Be at least 4 weeks since last anti-cancer treatment, radiation or surgery at the time of registration for protocol therapy. * No active cancer in addition to the epithelial ovarian cancer within the last 5 years, with the exception of: superficial skin cancer (basal cell or squamous cell skin carcinoma; carcinoma in situ of the cervix; Stage I endometrial cancer with less than 50% invasion of the myometrium, or other adequately treated Stage I or II cancer in complete remission. * Age \> 18 years at the time of consent * Written informed consent and HIPAA authorization for release of personal health information. * Females of childbearing potential must be willing to use an effective method of contraception (hormonal or barrier method of birth control; abstinence) from the time consent is signed until 90 days after treatment discontinuation * Females of childbearing potential must have a negative pregnancy test within 7 days prior to being registered for protocol therapy. Exclusion Criteria: * No known or suspected allergy to sorafenib or any agent given in the course of this trial. * No prior treatment with anti-angiogenesis therapy. * No active CNS metastases. * No treatment with any investigational agent within 30 days prior to being registered for protocol therapy. * No concurrent combination anti-retroviral therapy for the treatment of immunodeficiency. * No clinically significant infections requiring antibiotic treatment. * No evidence of bowel obstruction, malabsorption, or other contraindication to oral medication. * No serious non-healing wound, ulcer, or bone fracture. * No major surgery, open biopsy or significant traumatic injury within 28 days of registration for protocol therapy. * No use of St. John's Wort or rifampin (rifampicin) while on protocol therapy. * No condition that impairs patient's ability to swallow whole pills.
References
Publications (1)
- BACKGROUNDMatei D, Emerson RE, Schilder J, Menning N, Baldridge LA, Johnson CS, Breen T, McClean J, Stephens D, Whalen C, Sutton G. Imatinib mesylate in combination with docetaxel for the treatment of patients with advanced, platinum-resistant ovarian cancer and primary peritoneal carcinomatosis : a Hoosier Oncology Group trial. Cancer. 2008 Aug 15;113(4):723-32. doi: 10.1002/cncr.23605. PMID 18618737