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Fallopian Tube CancerPhase 3NCT00041080

Tamoxifen Compared With Thalidomide in Treating Women With Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer

A Phase 3 study testing tamoxifen citrate, thalidomide and laboratory biomarker analysis in people with Fallopian Tube Cancer and 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

Randomized phase III trial to compare the effectiveness of tamoxifen with that of thalidomide in treating women who have recurrent ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer. Estrogen can stimulate the growth of some types of cancer cells. Read more about this study

Who is it for?
Any age, women only
What is being tested?
tamoxifen citrate, thalidomide and laboratory biomarker analysis
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
139 participants
Where
1 siteUnited States
Study dates
Feb 2003to Jan 2011
Phase
Phase 3
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 Any age
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Histologically confirmed stage III or IV ovarian epithelial, fallopian tube, or primary peritoneal cancer that was treated with only 1 prior first-line chemotherapy regimen (platinum/taxane-based)
  • Clinically and radiologically without evidence of measurable and nonmeasurable disease
  • Symptomatic ascites and pleural effusions are considered nonmeasurable disease
  • Must have a biochemical recurrence
  • CA 125 must have been normal prior to or normalized during first-line therapy and then subsequently rose to exceed twice the upper limit of normal
  • Patients entering study with a CA 125 level less than 100 U/mL must be confirmed a second time within a period of not more than 4 weeks
Show all 40Show fewer
  • Patients with a CA 125 level of at least 100 U/mL may be entered without confirmatory measurement
  • Ineligible for a higher priority Gynecologic Oncology Group protocol (if one exists)
  • No history of brain metastases
  • Performance status - GOG 0-1
  • 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)
  • SGOT no greater than 2.5 times ULN
  • Alkaline phosphatase no greater than 2.5 times ULN
  • Creatinine no greater than 1.5 times ULN
  • Creatinine clearance at least 60 mL/min
  • No history of deep venous thrombosis
  • No prior cerebrovascular accident
  • No history of pulmonary embolism
  • No significant infection
  • No grade 2 or greater sensory or motor neuropathy
  • No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use at least 1 highly active method and at least 1 additional effective method of contraception for 4 weeks before, during, and for 4 weeks after study participation
  • No prior immunotherapy (e.g., interleukins)
  • No prior biological response modifiers (e.g., monoclonal antibodies)
  • No prior antiangiogenic agents (e.g., carbonic anhydrase inhibitors)
  • At least 3 weeks since prior anticancer chemotherapy and recovered
  • No prior or concurrent tamoxifen or other selective estrogen receptor modulators
  • At least 4 weeks since prior and no concurrent hormones (e.g., estrogen or progesterone)
  • At least 3 weeks since prior anticancer radiotherapy and recovered
  • At least 3 weeks since prior anticancer surgery and recovered
  • Prior second-look surgery without cytoreduction allowed
  • At least 3 weeks since other prior anticancer therapy and recovered
  • No prior interval cytoreduction
  • No concurrent full-dose therapeutic anticoagulation
  • No concurrent antiseizure medications for seizure disorder
  • No concurrent bisphosphonates (e.g., zoledronate)

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Gynecologic Oncology Group

    Philadelphia, Pennsylvania, 19103

Other trials in United States

About this study

Official title: A Randomized Study Of Tamoxifen Versus Thalidomide (NSC# 66847) In Patients With Biochemical-Recurrence-Only Epithelial Ovarian Cancer, Cancer Of The Fallopian Tube, And Primary Peritoneal Carcinoma After First Line Chemotherapy

Randomized phase III trial to compare the effectiveness of tamoxifen with that of thalidomide in treating women who have recurrent ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer. Estrogen can stimulate the growth of some types of cancer cells. Hormone therapy using tamoxifen may fight cancer by blocking the uptake of estrogen. Thalidomide may stop the growth of cancer by stopping blood flow to the tumor. It is not yet known whether thalidomide is more effective than tamoxifen in treating ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To compare the recurrence-free survival of women receiving tamoxifen or thalidomide for epithelial ovarian cancer, cancer of the fallopian tube, or primary peritoneal carcinoma who are in complete clinical remission following front-line treatment but have a high risk of recurrence due to rising serum CA-125.

II. To compare the toxicities and complications of these treatments.

SECONDARY OBJECTIVES:

  1. To determine whether changes in serum biomarker levels including VEGF and/or bFGF are independent of the randomization treatment.

II. To determine whether serum and plasma biomarker levels including VEGF and/or bFGF are associated with the duration of recurrence-free survival.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to the interval between completion of front-line chemotherapy and appearance of biochemical progression (6 months or less vs more than 6 months). Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive oral thalidomide once daily on days 1-28.

ARM II: Patients receive oral tamoxifen twice daily on days 1-28.

In both arms, courses repeat every 28 days for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients may receive additional therapy beyond 1 year at the investigator's discretion.

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

Being tested
tamoxifen citrate, thalidomide, laboratory biomarker analysis
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.

  • tamoxifen citrateDrug

    Also called Nolvadex, TAM, tamoxifen, TMX

    Given orally

  • thalidomideDrug

    Also called Kevadon, Synovir, THAL, Thalomid

    Given orally

  • laboratory biomarker analysisOther

    Correlative studies

Study groups in NCT00041080
Study groupRoleWhat they receive
Arm I (thalidomide)ExperimentalPatients receive oral thalidomide once daily on days 1-28.
Receives: Drug: thalidomide; Other: laboratory biomarker analysis
Arm II (tamoxifen)ExperimentalPatients receive oral tamoxifen twice daily on days 1-28.
Receives: Drug: tamoxifen citrate; Other: laboratory biomarker analysis

What is being measured

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

  1. Median Progression-free Survival

    Measured: from enrollment onto the study until first disease progression or death due to any cause

Timeline

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

  1. First posted27 Jan 2003 (estimated)
  2. Study startFeb 2003
  3. Primary completionJan 2011
  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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
139 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00041080
Sponsor's protocol ID
NCI-2012-02475
Other IDs
NCI-2012-02475, CDR0000069441, GOG-0198, GOG-0198, U10CA027469
Status last verified
Jul 2019
First submitted
8 Jul 2002
Last updated
30 Jul 2019

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing tamoxifen citrate, thalidomide and laboratory biomarker analysis in people with Fallopian Tube Cancer and 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 40 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 30 Jul 2019. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 16 Sep 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?

Median Progression-free Survival (time frame: from enrollment onto the study until first disease progression or death due to any cause). 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 NCT00041080.

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 30 Jul 2019.

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