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Recurrent Ovarian Epithelial CancerPhase 2NCT00313612

Oxaliplatin and Topotecan in Advance Ovarian Cancer

A Phase 2 study testing oxaliplatin and topotecan in people with Recurrent Ovarian Epithelial Cancer, run by National Cancer Institute (NCI) at 2 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 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Recurrent Ovarian Epithelial Cancer
What is being tested?
oxaliplatin and topotecan
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
39 participants
Where
2 sitesUnited States
Study dates
Jan 2006to 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 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
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  • 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

Who cannot join

  • No presence of any other active cancer
  • No uncontrolled intercurrent illness, including the following:
  • Infection
  • Symptomatic congestive heart failure
  • Unstable angina pectoris
  • Cardiac arrhythmia
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  • 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
  • No concurrent participation in another investigational trial
  • No other concurrent investigational agents
  • No other concurrent anticancer therapy

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • NYU Cancer Institute

    New York, New York, 10016

  • Montefiore Medical Center

    The Bronx, New York, 10467-2490

Other trials in United States

About this study

Official title: A Phase II Study of Oxaliplatin Combined With Continuous Infusion Topotecan as Chemotherapy for Patients With Previously Treated Ovarian Cancer

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. Estimate the overall clinical response rate (complete and partial responses) in patients with previously treated ovarian epithelial, primary peritoneal, or fallopian tube cancer treated with oxaliplatin and topotecan.

II. Determine the toxic effects in patients treated with this regimen.

SECONDARY OBJECTIVES:

  1. Estimate the time to progression and overall clinical response duration in patients treated with this regimen.

OUTLINE: This is an open-label, multicenter study. Patients are stratified according to response to prior platinum therapy (resistant vs sensitive).

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.

Being tested
oxaliplatin, topotecan
Medical subject headings
Carcinoma, Ovarian Epithelial

What participants receive

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

  • oxaliplatinDrug

    Also called 1-OHP, Dacotin, Dacplat, Eloxatin

    Given IV

  • topotecanDrug

    Also called hycamptamine, Hycamtin, SKF S-104864-A, TOPO

    Given IV

Study groups in NCT00313612
Study groupRoleWhat they receive
Treatment (oxaliplatin plus topotecan)ExperimentalPatients 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.
Receives: Drug: oxaliplatin; Drug: topotecan

What is being measured

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

  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.

    Measured: Every two cycles for up to 24 weeks.

Secondary outcomes (1)

  1. Time to Disease Progression by RECIST and/or CA 125

    Time to disease progression by RECIST and/or CA 125

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

Timeline

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

  1. First posted12 Apr 2006 (estimated)
  2. Study startJan 2006
  3. Primary completionMay 2011
  4. Study completionDec 2012

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
39 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00313612
Sponsor's protocol ID
NCI-2009-00053
Other IDs
NYU 03-67, N01CM62204
Status last verified
May 2013
First submitted
11 Apr 2006
Last updated
27 Nov 2015
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 24172094

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing oxaliplatin and topotecan in people with Recurrent Ovarian Epithelial Cancer, run by National Cancer Institute (NCI) at 2 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 10 inclusion and 18 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 27 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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 27 Nov 2015). 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?

Clinical Response Rate (Complete and Partial Response by RECIST and/or CA [Cancer Antigen] 125) (time frame: Every two cycles for up to 24 weeks.). 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 NCT00313612, 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 27 Nov 2015.

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