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Recurrent Ovarian Epithelial CancerPhase 2NCT00083122

Cisplatin and Flavopiridol in Treating Patients With Advanced Ovarian Epithelial Cancer or Primary Peritoneal Cancer

A Phase 2 study testing cisplatin, alvocidib and cisplatin/flavopiridol in people with Recurrent Ovarian Epithelial Cancer and Recurrent Primary Peritoneal Cavity Cancer, run by National Cancer Institute (NCI) 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

This phase II trial is studying how well giving cisplatin together with flavopiridol works in treating patients with advanced ovarian epithelial cancer or primary peritoneal cancer. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
cisplatin, alvocidib and cisplatin/flavopiridol
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
1 siteUnited States
Study dates
Apr 2004to May 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 confirmed ovarian epithelial or primary peritoneal cancer:
  • Advanced disease
  • Meets at least 1 of the following criteria:
  • Measurable disease;
  • Evaluable disease plus CA 125 >= 2 times post-treatment nadir
  • Treated with 1, and only 1, prior platin-containing chemotherapy regimen (e.g., paclitaxel or carboplatin-based) for ovarian epithelial or primary peritoneal cancer
Show all 44Show fewer
  • Prior treatment with the same regimen at first relapse allowed;
  • No more than 3 total chemotherapy regimens allowed provided exactly 1 has been platin-containing;
  • Must also have platin-resistant disease as defined for Group 1;
  • Rechallenge with a single regimen upon progression after a hiatus from therapy counts as a single regimen
  • Group 1, meeting 1 of the following criteria:
  • Patients who relapse during or < 6 months after completion of post-debulking chemotherapy;
  • "Platinum sensitive" patients in second relapse after having been treated/rechallenged with their initial regimen upon first relapse
  • Group 2 (Closed to accrual as of 3/10/06):
  • Patients who relapse >= 6 months after completion of post-debulking chemotherapy and are not retreated with the same or a different regimen
  • No CNS metastases
  • Performance status:
  • ECOG 0-2
  • Hematopoietic:
  • Absolute neutrophil count >= 1,500/mm3;
  • Platelet count >= 100,000/mm3;
  • Hemoglobin >= 10 g/dL (Note: May be supported with transfusion, epoetin alfa, or darbepoetin alfa)
  • Hepatic:
  • AST =< 2.5 times upper limit of normal (ULN);
  • Alkaline phosphatase =< 2.5 times ULN;
  • Bilirubin =< 1.5 times ULN
  • Renal:
  • Creatinine =< 1.5 times ULN
  • Cardiovascular:
  • No cardiac arrhythmia;
  • No cardiac failure
  • Not pregnant or nursing
  • Negative pregnancy test
  • More than 3 weeks since prior chemotherapy (6 weeks for nitrosoureas)
  • More than 3 weeks since prior radiotherapy
  • Recovered from all prior therapy
  • Fertile patients must use effective contraception
  • No other malignancy within the past 5 years except non-melanoma skin cancer or carcinoma in situ of the cervix
  • No diabetes
  • No peripheral neuropathy >= grade 2
  • No baseline diarrhea (>= 4 stools/day)
  • No uncontrolled infection
  • No other concurrent uncontrolled serious medical condition
  • No concurrent routine colony-stimulating factors

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Mayo Clinic

    Rochester, Minnesota, 55905

Other trials in United States

About this study

Official title: Phase II Trial of Flavopiridol and Cisplatin in Advanced Epithelial Ovarian and Primary Peritoneal Carcinomas

This phase II trial is studying how well giving cisplatin together with flavopiridol works in treating patients with advanced ovarian epithelial cancer or primary peritoneal cancer. Drugs used in chemotherapy, such as cisplatin and flavopiridol, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

Read the detailed description

OBJECTIVES:

  1. Determine the response rate, time to progression, and survival in patients with advanced ovarian epithelial or primary peritoneal cancer treated with cisplatin and flavopiridol.

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

OUTLINE: This is a multicenter study. Patients are accrued to two separate groups (Group 2 closed to accrual as of 3/10/06) .

GROUP 1: Patients receive cisplatin IV over 30 minutes and flavopiridol IV over 24 hours on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.

GROUP 2 (Closed to accrual as of 3/10/06): Patients receive cisplatin IV over 30 minutes and flavopiridol IV over 24 hours on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for up to 3 years.

Being tested
cisplatin, alvocidib, cisplatin/flavopiridol
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.

  • cisplatinDrug

    Also called CACP, CDDP, CPDD, DDP

    Given IV

  • alvocidibDrug

    Also called FLAVO, flavopiridol, HMR 1275, L-868275

    Given IV

  • cisplatin/flavopiridolDrug

    Given IV

Study groups in NCT00083122
Study groupRoleWhat they receive
Group 1ExperimentalPatients receive cisplatin IV over 30 minutes and flavopiridol IV over 24 hours on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Receives: Drug: cisplatin; Drug: alvocidib; Drug: cisplatin/flavopiridol
Group 2ExperimentalPatients receive cisplatin IV over 30 minutes and flavopiridol IV over 24 hours on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Receives: Drug: cisplatin; Drug: alvocidib; Drug: cisplatin/flavopiridol

What is being measured

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

  1. Proportion of Confirmed Tumor Responses Defined to be Either a Complete Response (CR) or Partial Response (PR)

    A Complete Response (CR) is defined as the disappearance of all target lesions and normalization of tumor biomarkers.

    A Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD.

    A confirmed tumor response is defined to be either a CR or PR noted as the objective status on 2 consecutive evaluations at least 4-6 weeks apart.

    Measured: 24 weeks

Secondary outcomes (2)

  1. Overall Survival

    Will be estimated using the method of Kaplan-Meier.

    Measured: Time from registration to date of last follow-up or death due to any cause, assessed up to 3 years

  2. Time to Progression

    Time to progression will be estimated using the method of Kaplan-Meier. Progression is defined as having at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.

    Measured: Time from registration to the date of progression or last follow-up, assessed up to 3 years

Timeline

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

  1. First posted17 May 2004 (estimated)
  2. Study startApr 2004
  3. Primary completionJul 2010
  4. Study completionMay 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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
45 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00083122
Sponsor's protocol ID
NCI-2009-00029
Other IDs
NCI-2009-00029, CDR0000363562, MC0261, 5876, N01CM62205, P30CA015083
Status last verified
Apr 2013
First submitted
14 May 2004
Last updated
21 May 2014

Publications

  • Bible KC, Peethambaram PP, Oberg AL, Maples W, Groteluschen DL, Boente M, Burton JK, Gomez Dahl LC, Tibodeau JD, Isham CR, Maguire JL, Shridhar V, Kukla AK, Voll KJ, Mauer MJ, Colevas AD, Wright J, Doyle LA, Erlichman C; Mayo Phase 2 Consortium (P2C); North Central Cancer Treatment Group (NCCTG). A phase 2 trial of flavopiridol (Alvocidib) and cisplatin in platin-resistant ovarian and primary peritoneal carcinoma: MC0261. Gynecol Oncol. 2012 Oct;127(1):55-62. doi: 10.1016/j.ygyno.2012.05.030. Epub 2012 Jun 1.

    PubMed 22664059

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing cisplatin, alvocidib and cisplatin/flavopiridol in people with Recurrent Ovarian Epithelial Cancer and Recurrent Primary Peritoneal Cavity Cancer, run by National Cancer Institute (NCI) 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 44 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 21 May 2014. 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?

Yes. Results are posted in the registry (first posted 14 May 2013). 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?

Proportion of Confirmed Tumor Responses Defined to be Either a Complete Response (CR) or Partial Response (PR) (time frame: 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 NCT00083122, 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 21 May 2014.

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