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

Phase 2
18 Years
Not Enrolling
Ovarian Cancer

Thank you

Trial Information

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

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)

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 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

7. Complete blood count (CBC) performed less than seven days prior to enrollment and
have an absolute neutrophil count >1.0 X 10E9/L, and a platelet count >100 X 10E9/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

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

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)

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

CA125 response rate with continuous-infusion topotecan and erlotinib

Outcome Description:

estimated total time from the start of the trial, response assessed at the beginning of every treatment cycle.

Outcome Time Frame:

3 years

Safety Issue:


Principal Investigator

Franco Muggia, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

New York University School of Medicine


United States: Food and Drug Administration

Study ID:

NYU 08-613



Start Date:

August 2009

Completion Date:

December 2012

Related Keywords:

  • Ovarian Cancer
  • chemotherapy
  • combination therapy
  • targeted therapy
  • second-line
  • Ovarian Neoplasms



Bellevue Hospital CenterNew York, New York  10016
NYU Clinical Cancer CenterNew York, New York  10016
Tisch HospitalNew York, New York  10016