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Primary Peritoneal Cavity CancerPhase 2NCT00093496

Gemcitabine Hydrochloride and Tanespimycin in Treating Patients With Recurrent Advanced Ovarian Epithelial or Peritoneal Cavity Cancer

A Phase 2 study testing gemcitabine hydrochloride and tanespimycin in people with Primary Peritoneal Cavity Cancer and Recurrent Ovarian Epithelial 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

Phase II trial to study the effectiveness of gemcitabine hydrochloride and tanespimycin in treating patients who have recurrent advanced ovarian epithelial or primary peritoneal cavity cancer. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
gemcitabine hydrochloride and tanespimycin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
29 participants
Where
1 siteUnited States
Study dates
Oct 2007to Mar 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

  • Diagnosis of ovarian epithelial or primary peritoneal cavity cancer
  • Relapsed disease
  • Persistent disease
  • Platinum-resistant disease, defined as having evidence of disease that would be expected to be non-responsive to additional platinum-containing regimens or contraindication to platinum-based chemotherapy and 1 of the following:
  • Failure to obtain a complete response to initial platinum therapy
  • Recurrence < 6 months after completing a platinum-containing regimen for initial or recurrent disease
Show all 64Show fewer
  • Any of the above situations and following treatment with additional chemotherapy regimens (e.g., non-platinum containing regimens)
  • Relative or absolute contraindication to platinum-based chemotherapy regimens (e.g., platinum allergy) as determine by the investigator
  • Measurable or evaluable disease
  • Patients with a rising CA 125 level, even in the absence of other indicators of disease, allowed provided CA 125 is ≥ 2 times upper limit of normal (ULN)
  • Patients with accessible disease must be willing to undergo tumor biopsies
  • No CNS metastases
  • Performance status - ECOG 0-2
  • WBC ≥ 3,000/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 9.0 g/dL
  • Bilirubin normal
  • Alkaline phosphatase ≤ 2.5 times ULN
  • AST ≤ 2.5 times ULN
  • Creatinine ≤ 1.5 times ULN
  • Ejection fraction > 40% by ECHO for patients with prior anthracycline therapy
  • No significant cardiac disease including any of the following:
  • New York Heart Association class III or IV heart disease
  • History of myocardial infraction within the past year
  • Uncontrolled dysrhythmias or requirement for antiarrhythmic drugs
  • Poorly controlled angina
  • No history of serious ventricular arrhythmia (i.e., ventricular tachycardia or ventricular fibrillation ≥ 3 beats in a row)
  • No history of QTc ≥ 500 msec
  • No active ischemic heart disease within the past 12 months
  • No congenital long QT syndrome
  • No left bundle branch block
  • No cardiac symptoms ≥ grade 2
  • No history of cardiac toxicity after receiving anthracyclines (e.g., doxorubicin hydrochloride, daunorubicin hydrochloride, mitoxantrone, bleomycin, or carmustine)
  • Does not meet the medicare criteria for home oxygen
  • No pulse oximetry at rest and exercise < 88%
  • No symptomatic pulmonary disease requiring medication including any of the following:
  • Dyspnea on or off exertion
  • Paroxysmal nocturnal dyspnea
  • Oxygen requirement
  • Significant pulmonary disease (e.g., chronic obstructive/restrictive pulmonary disease)
  • No pulmonary symptoms ≥ grade 2
  • No history of pulmonary toxicity after receiving anthracyclines (e.g., doxorubicin hydrochloride, daunorubicin hydrochloride, mitoxantrone, bleomycin, or carmustine)
  • K+, Mg ++, and Ca ++ normal
  • No seizure disorder
  • No uncontrolled infection
  • No history of serious allergic reaction to eggs
  • More than 4 weeks since prior immunotherapy
  • More than 4 weeks since prior biologic therapy
  • No concurrent immunotherapy
  • No concurrent routine or prophylactic colony-stimulating factors (e.g., filgrastim [G-CSF] or sargramostim [GM-CSF])
  • See Disease Characteristics
  • More than 4 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas) and recovered
  • Prior gemcitabine hydrochloride allowed provided 1 of the following criteria is met:
  • Patients have no prior exposure to gemcitabine hydrochloride
  • Patients who have prior exposure to gemcitabine hydrochloride as a single agent have experienced progressive disease while on treatment
  • No other concurrent chemotherapy
  • No prior radiotherapy to > 25% of bone marrow
  • No history of radiotherapy that potentially included the heart in the field (e.g., mantle)
  • Chest wall irradiation or other radiotherapy techniques that do not include the heart in the radiation field area allowed
  • More than 4 weeks since prior radiotherapy
  • More than 4 weeks since prior radiopharmaceuticals
  • No concurrent radiotherapy
  • No other concurrent investigational therapy
  • No concurrent medications that may prolong QTc

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: A Phase II Trial Of Gemcitabine in Combination With 17-Allylaminogeldamycin (17-AAG) In Advanced Epithelial Ovarian And Primary Peritoneal Carcinoma

Phase II trial to study the effectiveness of gemcitabine hydrochloride and tanespimycin in treating patients who have recurrent advanced ovarian epithelial or primary peritoneal cavity cancer. Drugs used in chemotherapy, such as gemcitabine hydrochloride and tanespimycin, work in different ways to stop tumor cells from dividing so they stop growing or die.

Read the detailed description

OBJECTIVES:

  1. Determine the response rate, time to progression, and survival of patients with recurrent advanced ovarian epithelial or primary peritoneal cavity cancer treated with gemcitabine hydrochloride and 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) (tanespimycin).

II. Determine the toxicity of this regimen in these patients. III. Correlate the effect of 17-AAG alone on chaperone and client proteins in tumor samples and peripheral blood mononuclear cells with response, time to progression, and survival of these patients.

OUTLINE: This is a multicenter study. Patients are stratified according to gemcitabine hydrochloride therapy (gemcitabine hydrochloride-naive/no prior exposure to gemcitabine hydrochloride vs gemcitabine hydrochloride-resistant/prior exposure to gemcitabine hydrochloride as a single agent with disease progression while on treatment). Patients receive tanespimycin intravenously (IV) over 2 hours on days 1 and 8 during course 1 and days 2 and 9 during subsequent courses and gemcitabine hydrochloride IV over 30 minutes on day 7 during course 1 and days 1 and 8 during subsequent courses. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months until disease progression and then every 6 months for up to 5 years.

Being tested
gemcitabine hydrochloride, tanespimycin
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.

  • gemcitabine hydrochlorideDrug

    Also called dFdC, difluorodeoxycytidine hydrochloride, gemcitabine, Gemzar

    Given IV

  • tanespimycinDrug

    Also called 17-AAG

    Given IV

Study groups in NCT00093496
Study groupRoleWhat they receive
Treatment (chemotherapy)ExperimentalPatients are stratified according to gemcitabine hydrochloride therapy (gemcitabine hydrochloride-naive/no prior exposure to gemcitabine hydrochloride vs gemcitabine hydrochloride-resistant/prior exposure to gemcitabine hydrochloride as a single agent with disease progression while on treatment). Patients receive tanespimycin IV over 2 hours on days 1 and 8 during course 1 and days 2 and 9 during subsequent courses and gemcitabine hydrochloride IV over 30 minutes on day 7 during course 1 and days 1 and 8 during subsequent courses. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months until disease progression and then every 6 months for up to 5 years.
Receives: Drug: gemcitabine hydrochloride; Drug: tanespimycin

What is being measured

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

  1. Proportion of Patients Who Experience a Confirmed Response According to Modified RECIST Criteria.

    Objective response will be measured using the modified RECIST criteria. A confirmed response requires an objective status of complete or partial response on 2 consecutive evaluations occurring 4 or more weeks apart.

    Complete Response (CR): Disappearance of all target lesions and normalization of tumor biomarkers.

    Partial Response (PR): At least a 30% decrease in the sum of the target lesions from the baseline.

    Measured: Participants were evaluated every 6 weeks on treatment, with median treatment length of 12 weeks (3 week minimum and 42 week maximum).

Secondary outcomes (3)

  1. Times to Progression

    Defined as the time from registration to the date of progression or last follow-up, whichever comes first. Estimated using the method of Kaplan-Meier

    Measured: Participants were evaluated every 6 weeks on treatment (maximum 42 weeks), and followed up to 5 years from registration.

  2. Overall Survival

    Defined as the time from registration to date of last follow-up or death due to any cause. Estimated using the method of Kaplan-Meier.

    Measured: Every 3 months until disease progression and then every 6 months for up to 5 years.

  3. Toxicity

    Defined by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 as an adverse event classified as either possibly, probably, or definitely related to study treatment. The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns.

    Measured: Participants were evaluated every 6 weeks on treatment (maximum 42 weeks)

Timeline

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

  1. First posted8 Oct 2004 (estimated)
  2. Study startOct 2007
  3. Primary completionApr 2010
  4. Study completionMar 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
29 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00093496
Sponsor's protocol ID
NCI-2009-00052
Other IDs
NCI-2009-00052, CDR0000388036, NCI-6307, MAYO-MC0362, MC0362, 6307, P30CA015083, N01CM62205
Status last verified
Oct 2011
First submitted
6 Oct 2004
Last updated
20 May 2014

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing gemcitabine hydrochloride and tanespimycin in people with Primary Peritoneal Cavity Cancer and Recurrent Ovarian Epithelial 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 64 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 20 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 10 Jul 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 Patients Who Experience a Confirmed Response According to Modified RECIST Criteria. (time frame: Participants were evaluated every 6 weeks on treatment, with median treatment length of 12 weeks (3 week minimum and 42 week maximum).). 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 NCT00093496.

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 20 May 2014.

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