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Ovarian CancerPhase 2NCT01003938

Topotecan With Erlotinib for Topotecan Pretreated Ovarian Cancer

A Phase 2 study testing Topotecan and Erlotinib in people with Ovarian Cancer, run by NYU Langone Health at 3 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Ovarian Cancer
What is being tested?
Topotecan and Erlotinib
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
3 sitesUnited States
Study dates
Aug 2009to Dec 2012
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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)

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Bellevue Hospital Center

    New York, New York, 10016

  • NYU Clinical Cancer Center

    New York, New York, 10016

  • Tisch Hospital

    New York, New York, 10016

Other trials in United States

About this study

Official title: Continuous Infusion Topotecan With Erlotinib for Topotecan Pretreated Ovarian Cancer: Tumor Features and Phase II/Pharmacokinetic Evaluation

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.

Read the 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)

Conditions
Ovarian Cancer
Being tested
Topotecan, Erlotinib
Keywords
chemotherapy, combination therapy, targeted therapy, second-line
Medical subject headings
Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TopotecanDrug

    Also called Topotecan hydrochloride, Hycamtin

  • ErlotinibDrug

    Also called Tarceva

Study groups in NCT01003938
Study groupRoleWhat they receive
topotecan and erlotinibExperimentalTopotecan 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.
Receives: Drug: Topotecan; Drug: Erlotinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. CA125 Response Rate With Continuous-infusion Topotecan and Erlotinib

    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.

    Measured: Up to 3 years

Secondary outcomes (5)

  1. CA125 Response Duration

    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.

    Measured: Up to 3 years

  2. CA125 Stable Disease Duration

    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.

    Measured: Up to 3 years

  3. Time to Progression

    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.

    Measured: Up to 3 years

  4. Overall Survival

    estimated total time from the start of the trial

    Measured: 4 years

  5. Toxicity Profile

    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.

    Measured: the whole treatment phase and 30 days post-treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Oct 2009 (estimated)
  2. Study startAug 2009
  3. Primary completionSep 2012
  4. Study completionDec 2012

Why it stopped: due to administrative issue and financial sponsor decision to suspend ovarian cancer studies

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01003938
Sponsor's protocol ID
NYU 08-613
Status last verified
May 2016
First submitted
27 Oct 2009
Last updated
30 Jun 2016
Data monitoring committee
Yes

Publications

  • Warner E, Liebes L, Levinson B, Downey A, Tiersten A, Muggia F. Continuous-infusion topotecan and erlotinib: a study in topotecan-pretreated ovarian cancer assessing shed collagen epitopes as a marker of invasiveness. Oncologist. 2014 Mar;19(3):250. doi: 10.1634/theoncologist.2013-0398. Epub 2014 Feb 21.

    PubMed 24563078

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Topotecan and Erlotinib in people with Ovarian Cancer, run by NYU Langone Health at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 30 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Jan 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

CA125 Response Rate With Continuous-infusion Topotecan and Erlotinib (time frame: Up to 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01003938, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2016; AzTrials last refreshed its copy on 8 Nov 2026.

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