AzTrials
AzTrials

Fallopian Tube CancerPhase 2NCT00275028

AZD2171 in Treating Patients With Recurrent Ovarian, Peritoneal, or Fallopian Tube Cancer

A Phase 2 study testing cediranib maleate in people with Fallopian Tube Cancer and Primary Peritoneal Serous Adenocarcinoma, 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
Search all trials

Trial summary

This phase II trial is studying how well AZD2171 works in treating patients with recurrent ovarian, peritoneal, or fallopian tube cancer. AZD2171 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
cediranib maleate
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
47 participants
Where
1 siteUnited States
Study dates
Oct 2005to Jan 2011
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

  • must have histologically or cytologically confirmed epithelial ovarian cancer, primary peritoneal serous cancer, or fallopian tube cancer
  • must have either measurable cancer by RECIST criteria or an elevated CA125
  • Subjects must be asymptomatic or minimally symptomatic
  • Prior therapy:
  • Prior chemotherapy must have included a first-line platinum-based regimen only
  • Prior hormonal-based therapy for ovarian, primary peritoneal serous or fallopian tube cancer is acceptable
Show all 24Show fewer
  • Up to two prior lines of chemotherapy in the recurrent setting are allowed
  • Toxic side effects related to prior chemotherapy or hormonal therapy must have resolved to less than or equal to grade 1 or to baseline (excluding alopecia), or for peripheral neuropathy to less than or equal to grade 2
  • Subjects may begin AZD2171 at least 3 weeks after their last dose of chemotherapy or hormonal therapy
  • Life expectancy of greater than 6 months
  • ECOG performance status 0-1 (Karnofsky >= 70%)
  • must have lab values within normal institutional limits
  • eligibility of patients receiving any medications or substances known to affect or with the potential to affect the activity or PK of AZD2171 will be determined following review of their case by the Principal Investigator
  • Subjects with treated limited stage basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the breast or cervix are eligible; subjects with stage I or II cancer treated with a curative intent are also eligible with no evidence of recurrent disease
  • No evidence of preexisting uncontrolled hypertension; if patient has hypertension, it must be medically controlled
  • AZD2171 has been shown to terminate fetal development in the rat, as expected for a process dependent on VEGF signaling; for this reason, women of child-bearing potential must have a negative pregnancy test prior to study entry; must agree to use adequate contraception; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
  • Ability to understand and the willingness to sign a written informed consent document- No therapeutic anticoagulation; the use of low dose warfarin (1 mg/day), intermittent doses of tPA (2 mg x 1), or heparin flushes to prophylax against central venous catheter-associated clots is permitted
  • Measurable or non-measurable disease on CT scan or MRI
  • Consider patients who have the following risk factors to be at increased risk; these patients should have increased monitoring:
  • Prior treatment with anthracyclines
  • Prior treatment with trastuzumab
  • A New York Heart Association classification of II controlled with treatment
  • Prior central thoracic radiation therapy (RT), including RT to the heart
  • History of myocardial infarction within 12 months

Who cannot join

  • Patients who have had chemotherapy, radiotherapy, or major surgery within 3 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 3 weeks earlier
  • Patients may not be receiving any other investigational agents nor have participated in an investigational trial within the past 3 weeks; subjects may not have received prior treatment affecting the VEGF pathway; subjects may not have received prior treatment with antibodies that may interfere with CA-125 measurements; subjects may not have received intraperitoneal therapy within the 4 weeks prior to starting AZD2171 and/or the treating physician must confirm the patient has recurrent disease
  • Patients may not be receiving any medication that may markedly affect renal function
  • Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to AZD2171
  • Mean QTc > 500 msec (with Bazett's correction) in screening electrocardiogram or history of familial long QT syndrome
Show all 14Show fewer
  • Uncontrolled intercurrent illness
  • Pregnant women are excluded from this study because AZD2171 is a VEGF inhibitor with known abortifacient effects; breastfeeding should be discontinued if the mother is treated with AZD2171
  • Major surgical procedure or medical interference with the peritoneum or pleura within 4 weeks of baseline CA-125 assessments
  • Subjects with a history of an active malignancy during the last 3 years except non-melanomatous skin cancer , in situ breast or cervical cancer or stage I or II cancer treated with a curative intent and no active cancer recurrence
  • HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with AZD2171
  • No therapeutic anti-coagulation; prophylaxis against central venous catheter-associated clots is permitted
  • A New York Heart Association classification of III or IV
  • Conditions requiring concurrent use of drugs or biologics with proarrhythmic potentiate

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02115

Other trials in United States

About this study

Official title: A Phase 2 Study of AZD2171 in Patients With Recurrent Ovarian, Primary Peritoneal Serous or Fallopian Tube Cancer

This phase II trial is studying how well AZD2171 works in treating patients with recurrent ovarian, peritoneal, or fallopian tube cancer. AZD2171 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor

Read the detailed description

PRIMARY OBJECTIVES:

  1. To determine the efficacy of AZD2171 in platinum sensitive and platinum insensitive disease, based on either RECIST criteria (for patients with measurable cancer radiographically) or clinical response benefit (modified Gynecologic Cancer Intergroup [GCIG] CA-125 response or stable disease for at least 16 weeks).

SECONDARY OBJECTIVES:

  1. To assess progression-free survival. II. To assess modified GCIG CA-125 response rate. III. To assess duration of modified GCIG CA-125 response. IV. To assess the safety of the recommended phase 2 dose of AZD2171 in this asymptomatic patient population.
  2. To explore the pharmacodynamic effects of AZD2171 by correlating clinical outcomes with an angiogenic profile derived from serial assessments of soluble VEGFR2, circulating endothelial cell levels, and VEGFR phosphorylation in circulating endothelial cells.

VI. To explore pharmacogenetic differences in kdr/flk-1, HIF1alpha, p53, and endothelial nitric oxide synthase (eNOS) in PBMCs from subjects who consent separately for pharmacogenetic studies.

VII. To determine whether oncogenic mutations predict response to AZD2171.

OUTLINE: This is a multicenter study. Patients are stratified according to disease sensitivity (platinum-sensitive disease vs platinum-insensitive disease).

Patients receive oral AZD2171 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for up to 2 years.

PROJECTED ACCRUAL: A total of 71 patients will be accrued for this study.

Being tested
cediranib maleate
Medical subject headings
Fallopian Tube Neoplasms, Carcinoma, Ovarian Epithelial

What participants receive

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

  • cediranib maleateDrug

    Also called AZD2171, Recentin

    Given orally

Study groups in NCT00275028
Study groupRoleWhat they receive
Treatment (cediranib maleate)ExperimentalPatients receive oral AZD2171 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Receives: Drug: cediranib maleate

What is being measured

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

  1. Clinical Response Benefit (Modified Gynecologic Cancer InterGroup [GCIG] Cancer Antigen [CA]-125 Response or Stable Disease) Based on the Response Evaluation Criteria in Solid Tumors (RECIST)

    Per Response Evaluation Criteria In Solid Tumors Criteria (RESIST)

    Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD Progressive Disease (PD): At least a 20% increase in the sum of the 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 Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started

    Measured: Up to 12 months

Secondary outcomes (1)

  1. Progression-free Survival

    Measured: Up to 2 years

Timeline

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

  1. First posted11 Jan 2006 (estimated)
  2. Study startOct 2005
  3. Primary completionMar 2010
  4. Study completionJan 2011

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
47 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00275028
Sponsor's protocol ID
NCI-2013-00036
Other IDs
05-170, U01CA062490
Status last verified
Jan 2013
First submitted
10 Jan 2006
Last updated
9 Nov 2015
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing cediranib maleate in people with Fallopian Tube Cancer and Primary Peritoneal Serous Adenocarcinoma, 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 24 inclusion and 14 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 9 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 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 9 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 Benefit (Modified Gynecologic Cancer InterGroup [GCIG] Cancer Antigen [CA]-125 Response or Stable Disease) Based on the Response Evaluation Criteria in Solid Tumors (RECIST) (time frame: Up to 12 months). 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 NCT00275028.

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 9 Nov 2015.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in