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Topotecan With Erlotinib for Topotecan Pretreated Ovarian Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01003938
Recruitment Status : Terminated (due to administrative issue and financial sponsor decision to suspend ovarian cancer studies)
First Posted : October 29, 2009
Results First Posted : January 16, 2014
Last Update Posted : June 30, 2016
OSI Pharmaceuticals
Information provided by (Responsible Party):
NYU Langone Health

Brief Summary:
This is a single arm phase II study with a combination of Hycamptin® (topotecan) and erlotinib for a minimum of 2 cycles in patients (18 yrs of age and older) with recurrent ovarian cancer previously treated with chemotherapy drug Hycamptin® (topotecan). Up to 30 patients will be enrolled in this study.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Drug: Topotecan Drug: Erlotinib Phase 2

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)

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Continuous Infusion Topotecan With Erlotinib for Topotecan Pretreated Ovarian Cancer: Tumor Features and Phase II/Pharmacokinetic Evaluation
Study Start Date : August 2009
Actual Primary Completion Date : September 2012
Actual Study Completion Date : December 2012

Arm Intervention/treatment
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.
Drug: Topotecan
Other Names:
  • Topotecan hydrochloride
  • Hycamtin

Drug: Erlotinib
Other Name: Tarceva

Primary Outcome Measures :
  1. CA125 Response Rate With Continuous-infusion Topotecan and Erlotinib [ Time Frame: Up to 3 years ]
    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.

Secondary Outcome Measures :
  1. CA125 Response Duration [ Time Frame: Up to 3 years ]
    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.

  2. CA125 Stable Disease Duration [ Time Frame: Up to 3 years ]
    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.

  3. Time to Progression [ Time Frame: Up to 3 years ]
    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.

  4. Overall Survival [ Time Frame: 4 years ]
    estimated total time from the start of the trial

  5. Toxicity Profile [ Time Frame: the whole treatment phase and 30 days post-treatment ]

    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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Histologically or cytologically proven, previously treated, epithelial ovarian cancer, and/or serous ovarian cancer.
  2. 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.
  3. 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)
  4. Age >= 18 years.
  5. Minimum life expectancy: 4 months.
  6. 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.
  7. 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.
  8. 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.
  9. 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.
  10. Central line access.
  11. 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.

  1. 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.
  2. Uncontrolled intercurrent illness not limited to infection, symptomatic congestive heart failure, or unstable angina pectoris, or cardiac arrhythmia.
  3. Acute toxicity of prior chemotherapy is still present
  4. History of severe allergic reaction to erlotinib
  5. Unresolved sequelae resulting from any surgical procedures.
  6. 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.
  7. 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.
  8. 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.
  9. Receipt of any investigational drug within 28 days before beginning treatment with study drug and/or concomitant treatment with other investigational agents.
  10. Patients with a history of poorly controlled gastrointestinal disorders that could affect absorption of erlotinib (e.g. Crohn's, ulcerative colitis, etc)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01003938

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United States, New York
Bellevue Hospital Center
New York, New York, United States, 10016
NYU Clinical Cancer Center
New York, New York, United States, 10016
Tisch Hospital
New York, New York, United States, 10016
Sponsors and Collaborators
NYU Langone Health
OSI Pharmaceuticals
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Principal Investigator: Franco Muggia, MD NYU Langone Health
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: NYU Langone Health Identifier: NCT01003938    
Other Study ID Numbers: NYU 08-613
First Posted: October 29, 2009    Key Record Dates
Results First Posted: January 16, 2014
Last Update Posted: June 30, 2016
Last Verified: May 2016
Keywords provided by NYU Langone Health:
combination therapy
targeted therapy
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Erlotinib Hydrochloride
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Topoisomerase I Inhibitors
Topoisomerase Inhibitors