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Primary Peritoneal CarcinomaPhase 2NCT00054119

Karenitecin in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer or Primary Peritoneal Cancer

A Phase 2 study testing Cositecan and Pharmacological Study in people with Primary Peritoneal Carcinoma and Recurrent Ovarian Carcinoma, run by Gynecologic Oncology Group at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Phase II trial to study the effectiveness of karenitecin in treating patients who have persistent or recurrent ovarian epithelial cancer or primary peritoneal cancer that has not responded to platinum-based treatment. Read more about this study

Who is it for?
Any age, women only
What is being tested?
Cositecan and Pharmacological Study
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
27 participants
Where
1 siteUnited States
Study dates
Jan 2003to 30 Sep 2005
Phase
Phase 2
Are there results?
None posted in the registry

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 Any age
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Histologically confirmed ovarian epithelial or primary peritoneal cancer
  • Recurrent or persistent disease
  • Platinum-resistant disease
  • At least 1 unidimensionally measurable lesion
  • At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
  • At least 1 target lesion to assess response (tumors within a previously irradiated field are designated as non-target)
Show all 39Show fewer
  • Ineligible for a higher priority GOG study or other phase II cytotoxic study for platinum-resistant disease
  • Performance status - GOG 0-2
  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • ALT no greater than 2.5 times ULN
  • Alkaline phosphatase no greater than 2.5 times ULN
  • Creatinine no greater than 1.5 times ULN
  • No myocardial infarction within the past 6 months
  • No cerebrovascular accident within the past 6 months
  • No transient ischemic attack within the past 6 months
  • No uncontrolled hypertension
  • No decompensated or uncontrolled chronic heart failure
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No neuropathy (sensory or motor) grade 2 or greater
  • No other invasive malignancies within the past 5 years except nonmelanoma skin cancer
  • No active infection requiring antibiotics
  • At least 3 weeks since prior biological or immunological agents
  • See Disease Characteristics
  • At least 3 weeks since prior chemotherapy and recovered
  • No more than 2 prior cytotoxic chemotherapy regimens, with no more than 1 non-platinum, non-taxane regimen
  • No prior karenitecin or camptothecin analogue/derivative
  • At least 1 week since prior hormonal therapy
  • Concurrent hormone replacement therapy allowed
  • See Disease Characteristics
  • At least 3 weeks since prior radiotherapy and recovered
  • No prior radiotherapy to more than 25% of marrow-bearing areas
  • Recovered from recent surgery
  • At least 3 weeks since prior therapy directed at this malignancy
  • No prior anticancer therapy that would preclude study therapy
  • No concurrent amifostine or other protective reagents

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Gynecologic Oncology Group of Arizona

    Phoenix, Arizona, 85012

Other trials in United States

About this study

Official title: A Phase II Evaluation of Karenitecin in the Third-Line Treatment of Persistent or Recurrent Epithelial Ovarian or Primary Peritoneal Carcinoma

Phase II trial to study the effectiveness of karenitecin in treating patients who have persistent or recurrent ovarian epithelial cancer or primary peritoneal cancer that has not responded to platinum-based treatment. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

Read the detailed description

OBJECTIVES:

  1. Determine the antitumor activity of karenitecin in patients with persistent or recurrent platinum-resistant ovarian epithelial or primary peritoneal cancer.

II. Determine the toxicity of this drug in these patients.

OUTLINE: This is an open-label study.

Patients receive karenitecin IV over 1 hour on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

Being tested
Cositecan, Pharmacological Study
Medical subject headings
Ovarian Neoplasms

What participants receive

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

  • CositecanDrug

    Also called BNP1350, DB 172, Karenitecin

    Given IV

  • Pharmacological StudyOther

    Also called pharmacological studies

    Correlative studies

Study groups in NCT00054119
Study groupRoleWhat they receive
TreatmentExperimentalPatients receive karenitecin IV over 1 hour on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Receives: Drug: Cositecan; Other: Pharmacological Study

What is being measured

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

  1. Frequency of objective response

    Measured: Up to 6 years

  2. Duration of objective response

    Measured: Up to 6 years

  3. Frequency of observed adverse effects, graded according to CTC version 2.0

    Measured: Up to 6 years

  4. Severity of observed adverse effects, graded according to CTC version 2.0

    Measured: Up to 6 years

  5. Survival time for all patients

    Measured: Up to 6 years

  6. Duration of progression-free interval for all patients

    Measured: Up to 6 years

Timeline

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

  1. First posted6 Feb 2003 (estimated)
  2. Study startJan 2003
  3. Primary completion30 Sep 2005

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
27 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00054119
Sponsor's protocol ID
GOG-0186D
Other IDs
NCI-2012-02514, CDR0000269898, BIONUM-KTN22307, GOG-0186D, GOG-0186D, U10CA027469
Status last verified
Jul 2017
First submitted
5 Feb 2003
Last updated
13 Jul 2017
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cositecan and Pharmacological Study in people with Primary Peritoneal Carcinoma and Recurrent Ovarian Carcinoma, run by Gynecologic Oncology Group at 1 site 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 39 inclusion and 0 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: finished, as of the sponsor's last update on 13 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Frequency of objective response (time frame: Up to 6 years). The study lists 6 primary outcomes in all. 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 NCT00054119.

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 13 Jul 2017.

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