NCT00313612

Brief Summary

This phase II trial is studying how well giving oxaliplatin together with topotecan works in treating patients with ovarian epithelial cancer, primary peritoneal cancer, or fallopian tube cancer. Drugs used in chemotherapy, such as oxaliplatin and topotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2006

Longer than P75 for phase_2

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 11, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 12, 2006

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
3 years until next milestone

Results Posted

Study results publicly available

November 27, 2015

Completed
Last Updated

November 27, 2015

Status Verified

May 1, 2013

Enrollment Period

5.3 years

First QC Date

April 11, 2006

Results QC Date

April 13, 2015

Last Update Submit

October 27, 2015

Conditions

Recurrent Ovarian Epithelial Cancer

Outcome Measures

Primary Outcomes (1)

  • Clinical Response Rate (Complete and Partial Response by RECIST and/or CA [Cancer Antigen] 125)

    Tumor response was assessed every two cycles by CT/MRI using RECIST (Response Evaluation Criteria in Solid Tumors) criteria. Per Response Evaluation Criteria in Solid Tumors (RECIST 1.0) for target lesions: Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): \>= 30% decrease in the sum of the longest diameter (LD) of target lesions; Overall Response (OR) = CR + PR.

    Every two cycles for up to 24 weeks.

Secondary Outcomes (1)

  • Time to Disease Progression by RECIST and/or CA 125

    Tumor measurements will be performed every 8 weeks until the date of first documented progression up to 100 weeks

Study Arms (1)

Treatment (oxaliplatin plus topotecan)

EXPERIMENTAL

Patients receive oxaliplatin IV over 2 hours on days 1 and 15 and topotecan IV continuously on days 1-14. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed at 30 days.

Drug: oxaliplatinDrug: topotecan

Interventions

oxaliplatinDRUG

Given IV

Also known as: 1-OHP, Dacotin, Dacplat, Eloxatin, L-OHP
Treatment (oxaliplatin plus topotecan)
topotecanDRUG

Given IV

Also known as: hycamptamine, Hycamtin, SKF S-104864-A, TOPO
Treatment (oxaliplatin plus topotecan)

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically or cytologically confirmed ovarian epithelial, primary peritoneal, or fallopian tube cancer
  • Meets 1 of the following criteria for response to prior platinum-based therapy:
  • Platinum-resistant disease, defined as a disease-free interval of \< 6 months after prior platinum-based therapy OR progressive disease on a platinum-containing regimen
  • Platinum-sensitive disease, defined as a disease-free interval of \> 6 months after prior platinum-based therapy
  • Measurable or evaluable disease: Measurable disease is characterized as lesions reproducibly measurable in 1 dimension; evaluable disease is defined as known disease with CA125 levels \> 50 U/mL on 2 occasions \>= 1 week apart
  • Previously treated with a taxane and platinum-based regimen, only 1 prior platinum-based regimen, including IV or intraperitoneal consolidation, one additional non-platinum and non-topotecan chemotherapy regimen allowed
  • Life expectancy \>= 4 months
  • Total bilirubin =\< 1.5 times upper limit of normal (ULN)
  • AST =\< 2.5 times ULN (5 times ULN if liver metastases are present)
  • Creatinine =\< 1.5 times ULN AND creatinine clearance \> 40 mg/dL

You may not qualify if:

  • No presence of any other active cancer
  • No uncontrolled intercurrent illness, including the following:
  • Infection
  • Symptomatic congestive heart failure
  • Unstable angina pectoris
  • Cardiac arrhythmia
  • No history of severe allergy to platinum compounds
  • (Mild reaction (skin only) allowed provided a negative skin test is obtained)
  • No history of allergic reaction to appropriate antiemetics (e.g., 5HT3 antagonists)
  • Recovered from prior chemotherapy
  • At least 2 weeks since prior radiotherapy and recovered
  • At least 4 weeks since prior investigational drugs
  • No prior radiotherapy to the whole pelvic field
  • No unresolved sequelae resulting from any surgical procedures
  • No concurrent colony-stimulating factors (e.g., filgrastim \[G-CSF\] or sargramostim \[GM-CSF\]) during topotecan infusion
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

NYU Cancer Institute

New York, New York, 10016, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467-2490, United States

Location

Related Publications (1)

  • Stein SM, Tiersten A, Hochster HS, Blank SV, Pothuri B, Curtin J, Shapira I, Levinson B, Ivy P, Joseph B, Guddati AK, Muggia F. A phase 2 study of oxaliplatin combined with continuous infusion topotecan for patients with previously treated ovarian cancer. Int J Gynecol Cancer. 2013 Nov;23(9):1577-82. doi: 10.1097/IGC.0b013e3182a809e0.

    PMID: 24172094RESULT

MeSH Terms

Conditions

Carcinoma, Ovarian Epithelial

Interventions

OxaliplatinTopotecantrioctyl phosphine oxide

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsOvarian NeoplasmsEndocrine Gland NeoplasmsNeoplasms by SiteOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsCamptothecinAlkaloidsHeterocyclic Compounds

Results Point of Contact

Title
Lisa Escobar-Peralta
Organization
Montefiore Medical Center
lescobar@montefiore.org
718-379-6866

Study Officials

  • Amy Tiersten

    Montefiore Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

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

Study Record Dates

First Submitted

April 11, 2006

First Posted

April 12, 2006

Study Start

January 1, 2006

Primary Completion

May 1, 2011

Study Completion

December 1, 2012

Last Updated

November 27, 2015

Results First Posted

November 27, 2015

Record last verified: 2013-05

Locations

US(2)