Topotecan With Erlotinib for Topotecan Pretreated Ovarian Cancer

NCT01003938 | Terminated Phase 2 Results DMC

• 1 other identifier: NYU 08-613
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 3

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.

Conditions

Ovarian Cancer

Keywords

chemotherapy; combination therapy; targeted therapy; second-line

Outcome Measures

Primary Outcomes (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.

  Up to 3 years

Secondary Outcomes (5)

• CA125 Response Duration

  Up to 3 years

• CA125 Stable Disease Duration

  Up to 3 years

• Time to Progression

  Up to 3 years

• Overall Survival

  4 years

• Toxicity Profile

  the whole treatment phase and 30 days post-treatment

Study Arms (1)

topotecan and erlotinib

EXPERIMENTAL

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; Drug: Erlotinib

Interventions

Topotecan DRUG

Also known as: Topotecan hydrochloride, Hycamtin

topotecan and erlotinib

Erlotinib DRUG

Also known as: Tarceva

topotecan and erlotinib

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• NYU Langone Health: lead
• OSI Pharmaceuticals: collaborator

Study Sites (3)

Bellevue Hospital Center

New York, New York, 10016, United States

Location

NYU Clinical Cancer Center

New York, New York, 10016, United States

Location

Tisch Hospital

New York, New York, 10016, United States

Location

Related Publications (1)

• 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.

  PMID: 24563078 DERIVED

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Topotecan; Erlotinib Hydrochloride

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Franco Muggia, MD
• Organization: NYU Cancer Institute

franco.muggia@nyumc.org

212-263-6485

Study Officials

• Franco Muggia, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2009
• First Posted: October 29, 2009
• Study Start: August 1, 2009
• Primary Completion: September 1, 2012
• Study Completion: December 1, 2012
• Last Updated: June 30, 2016
• Results First Posted: January 16, 2014

Record last verified: 2016-05

Locations

US (3)