- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01003938
Topotecan With Erlotinib for Topotecan Pretreated Ovarian Cancer
Continuous Infusion Topotecan With Erlotinib for Topotecan Pretreated Ovarian Cancer: Tumor Features and Phase II/Pharmacokinetic Evaluation
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
On Day 1 of each treatment cycle, topotecan 0.4 mg/m^2/day will be administered via continuous infusion for 9 days beginning on Day 1 of every 21 day cycle. Additionally, patients will receive erlotinib 150 mg daily Days 1-9 in a cycle of 21 days. Thereafter both drugs will be given as long as patient benefit continues. Treatment will be administered on an inpatient or outpatient basis, repeating administration on an every 3 week cycle.
A cycle will be one three-week course of the erlotinib-topotecan regimen (the cycle could be extended to 4 weeks if blood studies at 21 days result in treatment delay).
The dose of topotecan will be calculated as follows:
BSA (m^2) X drug dose (mg/m^2) = dose (mg)
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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New York
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New York, New York, United States, 10016
- Nyu Clinical Cancer Center
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New York, New York, United States, 10016
- Bellevue Hospital Center
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New York, New York, United States, 10016
- Tisch Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Histologically or cytologically proven, previously treated, epithelial ovarian cancer, and/or serous ovarian cancer.
- Evaluable disease with CA125 levels two times the upper limit of normal for the institution (>50u/ml ) on two occasions at least one week apart is required in order to apply CA-125 response criteria.
- Previously treated for ovarian cancer with a taxane and platinum based regimen. and an additional topotecan regimen (any number of chemotherapy or biologic therapies are allowed; including prior erlotinib are allowed)
- Age >= 18 years.
- Minimum life expectancy: 4 months.
- ECOG (Eastern Cooperative Oncology Group) performance status 0,1, or 2. 0: Fully active, unrestricted activities of daily living. 1: Ambulatory, but restricted in strenuous activity. 2: Ambulatory, and capable of self care. Unable to work. Out of bed for greater than 50% of waking hours.
- Complete blood count (CBC) performed less than seven days prior to enrollment and have an absolute neutrophil count >1.0 X 10^9/L, and a platelet count >100 X 10^9/L.
- Serum chemistry panel drawn less than seven days prior to enrollment and have a total bilirubin <= 1.5 X the institutional upper limit of normal (IULN), or SGOT/AST is < 2.5 X IULN.
- Serum creatinine <= 1.5 X institutional upper limit of normal (IULN). If the serum creatinine level is >= 1.5 IULN, but the serum creatinine clearance >= 50 mg/dL, then the subject can enter the study.
- Central line access.
- Signed written informed consent (approved by the Institutional Review Board [IRB]/Ethics Committee) obtained prior to study entry.
Exclusion Criteria:
If the answer to any of the exclusion criteria is YES, the subject is NOT ELIGIBLE for the study.
- Presence of active cancer other than that described in Section 3.1.criteria (a), with the exception of a diagnosis of synchronous occurrence of adenocarcinoma in ovary and uterus.
- Uncontrolled intercurrent illness not limited to infection, symptomatic congestive heart failure, or unstable angina pectoris, or cardiac arrhythmia.
- Acute toxicity of prior chemotherapy is still present
- History of severe allergic reaction to erlotinib
- Unresolved sequelae resulting from any surgical procedures.
- Symptomatic, untreated brain metastases. Patients with untreated brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
- Lactating or pregnant. The investigational agent topotecan may be toxic to the developing fetus or nursing infant and poses unknown health risks. Documentation of a negative, serum HCG pregnancy test is required for women of child bearing potential (WOCBP) within 2 weeks prior to the start of treatment. WOCBP is defined as women who have not been naturally postmenopausal for at least 12 consecutive months or no previous surgical sterilization. A negative pregnancy test within 2 weeks prior to start of treatment is required.
- Women of childbearing potential must use effective contraception throughout the time they are on study. Before entering this trial, patients must be made aware of the risk in becoming pregnant.
- Receipt of any investigational drug within 28 days before beginning treatment with study drug and/or concomitant treatment with other investigational agents.
- Patients with a history of poorly controlled gastrointestinal disorders that could affect absorption of erlotinib (e.g. Crohn's, ulcerative colitis, etc)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: topotecan and erlotinib
Topotecan 0.4 mg/m^2/day administered via continuous infusion for 9 days beginning on Day 1, every 21 days cycle; erlotinib 150 mg daily for 9 days every 21 days cycle.
Both drugs will be given for a minimum of 2 cycles.
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Other Names:
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
CA125 Response Rate With Continuous-infusion Topotecan and Erlotinib
Time Frame: Up to 3 years
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Response was assessed after every treatment cycle.
Response rate is defined as number of the patients who experienced complete or partial CA125 response (CR or PR).
CR: normalization of the CA125 value, determined by 2 observations not less than 4 weeks apart; PR: CA125 decreases by >50% and is confirmed to be 50% or greater on a subsequent determination at least one month later.
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Up to 3 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
CA125 Response Duration
Time Frame: Up to 3 years
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Response duration is measured from the time measurement criteria for CA125 CR/PR at the first met until the first date that recurrent or progressive disease is objectively documented.
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Up to 3 years
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CA125 Stable Disease Duration
Time Frame: Up to 3 years
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Stable disease (SD) duration is measured from the tile of start of therapy until the criteria for progression are met.
SD: CA125 decreases <50% or increases <100%.
Disease progression: CA125 doubles the value of baseline, or more, over time.
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Up to 3 years
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Time to Progression
Time Frame: Up to 3 years
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Time to progression is defined as the time from first study drug administration until the first day radiological and /or symptomatic disease progression is documented, or until death in the absence of progression.
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Up to 3 years
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Overall Survival
Time Frame: 4 years
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estimated total time from the start of the trial
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4 years
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Toxicity Profile
Time Frame: the whole treatment phase and 30 days post-treatment
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Number of participants (patients) who experienced AEs. Dry skin, dry eye, acne, erythema, rash, pruritus, and diarrhea were related erlotinib; dehydration, anemia, leukopenia, nausea, vomiting, platelets, and fatigue were realted to topotcan. |
the whole treatment phase and 30 days post-treatment
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Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Genital Neoplasms, Female
- Endocrine System Diseases
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Endocrine Gland Neoplasms
- Ovarian Neoplasms
- Carcinoma, Ovarian Epithelial
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Topoisomerase Inhibitors
- Protein Kinase Inhibitors
- Topoisomerase I Inhibitors
- Erlotinib Hydrochloride
- Topotecan
Other Study ID Numbers
- NYU 08-613
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Ovarian Cancer
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Roswell Park Cancer InstituteCompletedFallopian Tube Carcinoma | Primary Peritoneal Carcinoma | Stage IIA Ovarian Cancer | Stage IIB Ovarian Cancer | Stage IIC Ovarian Cancer | Stage IIIA Ovarian Cancer | Stage IIIB Ovarian Cancer | Stage IIIC Ovarian Cancer | Stage IV Ovarian Cancer | Stage IA Ovarian Cancer | Stage IB Ovarian Cancer | Stage IC... and other conditionsUnited States
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City of Hope Medical CenterNational Cancer Institute (NCI)CompletedCancer Survivor | Stage IIIA Ovarian Epithelial Cancer | Stage IIIB Ovarian Epithelial Cancer | Stage IIIC Ovarian Epithelial Cancer | Stage IIA Ovarian Epithelial Cancer | Stage IIB Ovarian Epithelial Cancer | Stage IIC Ovarian Epithelial Cancer | Stage IA Ovarian Epithelial Cancer | Stage IB Ovarian... and other conditionsUnited States
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Massachusetts General HospitalJohns Hopkins University; M.D. Anderson Cancer Center; National Cancer Institute... and other collaboratorsRecruitingOvarian Neoplasms | Fallopian Tube Neoplasms | Stage III Ovarian Cancer AJCC v8 | Stage IIIA Ovarian Cancer AJCC v8 | Stage IIIA1 Ovarian Cancer AJCC v8 | Stage IIIA2 Ovarian Cancer AJCC v8 | Stage IIIB Ovarian Cancer AJCC v8 | Stage IIIC Ovarian Cancer AJCC v8 | Stage IV Ovarian Cancer AJCC v8 | Stage... and other conditionsUnited States
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Gynecologic Oncology GroupNational Cancer Institute (NCI)CompletedOvarian Clear Cell Cystadenocarcinoma | Ovarian Endometrioid Adenocarcinoma | Ovarian Seromucinous Carcinoma | Ovarian Serous Cystadenocarcinoma | Stage IV Ovarian Germ Cell Tumor | Ovarian Sarcoma | Malignant Ovarian Epithelial Tumor | Ovarian Carcinosarcoma | Ovarian Brenner Tumor | Ovarian Mucinous... and other conditionsUnited States
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Eve RodlerNot yet recruitingBreast Cancer | Ovarian Cancer | Breast Neoplasm | Breast Carcinoma | Breast Cancer Stage IV | Breast Cancer Stage I | Breast Cancer Stage II | Invasive Breast Cancer | Cancer, Breast | Breast Cancer Stage III | Ovary Cancer | Malignant Tumor of Breast | Ovarian Cancer Stage IIIC | Ovarian Cancer Stage IV | Ovarian Cancer... and other conditionsUnited States
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Gynecologic Oncology GroupNational Cancer Institute (NCI)RecruitingStage IIIA Ovarian Cancer | Stage IIIB Ovarian Cancer | Stage IIIC Ovarian Cancer | Stage IV Ovarian CancerUnited States
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Gynecologic Oncology GroupNational Cancer Institute (NCI)CompletedStage IIA Fallopian Tube Cancer | Stage IIA Ovarian Cancer | Stage IIB Fallopian Tube Cancer | Stage IIB Ovarian Cancer | Stage IIC Fallopian Tube Cancer | Stage IIC Ovarian Cancer | Stage IIIA Fallopian Tube Cancer | Stage IIIA Ovarian Cancer | Stage IIIA Primary Peritoneal Cancer | Stage IIIB Fallopian... and other conditionsUnited States
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University of WashingtonNational Cancer Institute (NCI)CompletedCaregiver | Stage IIIA Ovarian Cancer | Stage IIIB Ovarian Cancer | Stage IIIC Ovarian Cancer | Stage IV Ovarian CancerUnited States
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Sidney Kimmel Cancer Center at Thomas Jefferson...CompletedStage I Breast Cancer | Stage I Uterine Corpus Cancer | Stage II Uterine Corpus Cancer | Stage III Uterine Corpus Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIA Breast Cancer | Stage IIB Breast Cancer | Stage... and other conditionsUnited States
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University of WashingtonMinnesota Ovarian Cancer AllianceTerminatedStage III Ovarian Cancer AJCC v8 | Stage IIIA Ovarian Cancer AJCC v8 | Stage IIIA1 Ovarian Cancer AJCC v8 | Stage IIIA2 Ovarian Cancer AJCC v8 | Stage IIIB Ovarian Cancer AJCC v8 | Stage IIIC Ovarian Cancer AJCC v8 | Stage IV Ovarian Cancer AJCC v8 | Stage IVA Ovarian Cancer AJCC v8 | Stage IVB Ovarian... and other conditionsUnited States
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National Cancer Institute (NCI)University of Chicago; City of Hope Medical Center; University of Southern California and other collaboratorsCompleted
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AVEO Pharmaceuticals, Inc.Biodesix, Inc.TerminatedNon-small Cell Lung CancerKorea, Republic of, United States, Australia, Taiwan, Singapore, Hong Kong, Italy
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M.D. Anderson Cancer CenterCompletedAdvanced CancersUnited States
-
PfizerCompletedCarcinoma, Non-Small-Cell LungUnited States
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Fox Chase Cancer CenterMillennium Pharmaceuticals, Inc.TerminatedNon-small Cell Lung Cancer Metastatic | Non-small Cell Lung Cancer RecurrentUnited States
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University of ChicagoNational Cancer Institute (NCI)CompletedMalignant Peritoneal MesotheliomaUnited States
-
Grupo de Investigación Clínica en Oncología RadioterapiaCompletedSquamous Cell Carcinoma of the Head and NeckSpain
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Kyowa Kirin Co., Ltd.TerminatedNon-small-cell Lung CancerJapan
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Merck Sharp & Dohme LLCCompleted
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Duke UniversityBristol-Myers Squibb; Genentech, Inc.Completed