Sorafenib + Topotecan for Platinum-Resistant Recurrent Ovarian Cancer
This study has been terminated.
(Study closed to accrual due unfavorable interim analysis)
Sponsor:
Hoosier Oncology Group
Collaborator:
Bayer
Information provided by:
Hoosier Oncology Group
ClinicalTrials.gov Identifier:
NCT00526799
First received: September 5, 2007
Last updated: April 28, 2011
Last verified: April 2011
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Ovarian Cancer |
Biological: Sorafenib Drug: Topotecan |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by Hoosier Oncology Group:
Primary Outcome Measures:
- To find the maximum tolerated dose (MTD) for the phase II component and evaluate the safety and toxicity of the combination Sorafenib plus Topotecan in patients with recurrent or resistant epithelial ovarian cancer. [ Time Frame: Phase I ] [ Designated as safety issue: Yes ]
- To assess response in patients with recurrent or resistant epithelial ovarian cancer treated with Sorafenib plus Topotecan. [ Time Frame: Phase II ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- To determine the progression-free survival of patients treated with Sorafenib plus Topotecan. [ Time Frame: Phase II ] [ Designated as safety issue: No ]
- To determine the rate of clinical benefit defined as the number of patients experiencing an objective response or a CA125 response [ Time Frame: Phase II ] [ Designated as safety issue: No ]
| Enrollment: | 30 |
| Study Start Date: | September 2007 |
| Study Completion Date: | August 2010 |
| Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
Topotecan + Sorafenib. Assigned cohort dose for phase I (up to 12 patients); maximum tolerated dose for phase II (21 total patients).
|
Biological: Sorafenib
Dose level -1: 200mg po daily Dose level 1: 400mg po daily Dose level 2: 400mg po bid Dose is escalated until DLT observed. 4mg/m2 weekly, 3 weeks on and one week off.
|
Detailed Description:
OUTLINE: This is a multi-center study.
- Topotecan: 4mg/m2 weekly, 3 weeks on and one week off.
- Sorafenib: Assigned cohort dose for phase I (up to 12 patients) Maximum tolerated dose for phase II (21 total patients)
Cycles will consist of 4 weeks (28 days) with disease evaluations every 8 weeks.
Non-PD and acceptable toxicity: Patients will continue protocol therapy PD or unacceptable toxicity: Patients will discontinue protocol therapy
ECOG performance status 0-1
Life expectancy: Three (3) months
Hematopoietic:
- White blood cell count (WBC) > 3 K/mm3
- Hemoglobin (Hgb) > 9 g/dL
- Platelets > 100 K/mm3
- Absolute neutrophil count (ANC) > 1.5 K/mm3
- INR < 1.5 or a PTT within normal limits. NOTE: Patients receiving anti-coagulation treatment with an agent such as warfarin or heparin may be allowed to participate.
- No evidence or history of bleeding diathesis or coagulopathy.
Hepatic:
- Bilirubin < 1.5 x ULN
- Aspartate aminotransferase (AST, SGOT) < 2.5 x ULN
- Alanine aminotransferase (ALT, SGPT) < 2.5 x ULN
- Alkaline phosphate < 2.5 x ULN
Renal:
- Creatinine < 1.5 x ULN
Cardiovascular:
- No history of myocardial infarction or angina pectoris or angina equivalent within 6 months prior to registration for protocol therapy (the patient may not be on anti-anginal or anti-arrhythmic medications), or have uncontrolled hypertension or congestive heart failure > class II NYHA
Pulmonary:
- No thrombolic or embolic events such as a cerebrovascular accident, including transient ischemic attacks within the past 6 months.
- No pulmonary hemorrhage/bleeding event > CTCAE Grade 2 within 28 days prior to registration for protocol therapy.
- No non-pulmonary hemorrhage/bleeding event > CTCAE Grade 3 within 28 days prior to registration for protocol therapy.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00526799
Locations
| United States, Illinois | |
| Medical & Surgical Specialists, LLC | |
| Galesburg, Illinois, United States, 61401 | |
| United States, Indiana | |
| Oncology Hematology Associates of SW Indiana | |
| Evansville, Indiana, United States, 47714 | |
| Fort Wayne Oncology & Hematology, Inc | |
| Fort Wayne, Indiana, United States, 46815 | |
| Indiana University Simon Cancer Center | |
| Indianapolis, Indiana, United States, 46202 | |
| St. Vincent Hospital Cynecologic Oncology | |
| Indianapolis, Indiana, United States, 46260 | |
| Arnett Cancer Care | |
| Lafayette, Indiana, United States, 47904 | |
| Medical Consultants, P.C. | |
| Muncie, Indiana, United States, 47303 | |
| United States, New York | |
| Schwartz Gynecologic Oncology, PLLC | |
| Brightwaters, New York, United States, 11718 | |
Sponsors and Collaborators
Hoosier Oncology Group
Bayer
Investigators
| Study Chair: | Daniela Matei, M.D. | Hoosier Oncology Group, Inc. |
More Information
Additional Information:
No publications provided
| Responsible Party: | Daniela Matei, M.D., Hoosier Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00526799 History of Changes |
| Other Study ID Numbers: | GYN06-111 |
| Study First Received: | September 5, 2007 |
| Last Updated: | April 28, 2011 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Ovarian Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders |
Topotecan Sorafenib Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Protein Kinase Inhibitors |
ClinicalTrials.gov processed this record on May 23, 2013