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Gestational Trophoblastic TumorPhase 2NCT00096187

Pemetrexed Disodium in Treating Patients With Recurrent or Persistent Low-Risk Gestational Trophoblastic Tumor After a Molar Pregnancy

A Phase 2 study testing pemetrexed disodium in people with Gestational Trophoblastic Tumor, run by Gynecologic Oncology Group at 25 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

RATIONALE: Drugs used in chemotherapy, such as pemetrexed disodium, work in different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: This phase II trial is studying how well pemetrexed disodium works in treating patients with recurrent or persistent low-risk gestational trophoblastic… Read more about this study

Who is it for?
Ages Up to 120 years, women only
Conditions the study is for
Gestational Trophoblastic Tumor
What is being tested?
pemetrexed disodium
How many people
55 participants
Where
25 sitesUnited States
Study dates
Jul 2005to 23 Jul 2007
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 Up to 120 years
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

DISEASE CHARACTERISTICS:

  • Diagnosis of low-risk post-molar gestational trophoblastic tumor, defined as 1 of the following:
  • Increasing human chorionic gonadotropin (hCG) levels on ≥ 3 consecutive measurements taken over ≥ a 2-week period
  • Less than 10% decrease of hCG levels on 4 measurements taken over ≥ a 3-week period
  • Persistent or recurrent disease
  • Histologically confirmed complete or partial mole on initial evacuation
  • Prior pregnancy ≤ 12 months ago
  • No histologically confirmed choriocarcinoma or placental site trophoblastic tumor on initial evacuation
  • Failed only 1 prior dactinomycin or methotrexate therapy (with or without leucovorin calcium)
  • WHO score 2-6
  • No evidence of metastatic disease, except to the lung or vagina, on physical exam, chemistry, chest X-ray, and ultrasound
  • No liver, spleen, brain, kidney, or gastrointestinal tract metastases
  • No more than 8 metastatic lesions

PATIENT CHARACTERISTICS:

Age

  • Any age

Performance status

  • GOG 0-1

Life expectancy

  • Not specified

Hematopoietic

  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Granulocyte count ≥ 1,500/mm^3

Hepatic

  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • SGOT ≤ 3 times ULN
  • Alkaline phosphatase ≤ 3 times ULN

Renal

  • Creatinine ≤ 1.5 mg/dL
  • Creatinine clearance ≥ 45 mL/min

Other

  • Not pregnant or nursing
  • Fertile patients must use effective contraception during and for 3 months after study participation
  • No significant infection
  • No other invasive malignancy within the past 5 years except nonmelanoma skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No concurrent prophylactic filgrastim (G-CSF) unless for recurrent neutropenic complications
  • No concurrent prophylactic thrombopoietic agents unless for recurrent grade 4 thrombocytopenia

Chemotherapy

  • See Disease Characteristics
  • At least 7 days since prior dactinomycin or methotrexate (with or without leucovorin calcium) and recovered
  • No prior pemetrexed disodium
  • No other prior chemotherapy

Endocrine therapy

  • Not specified

Radiotherapy

  • At least 14 days since prior radiotherapy and recovered
  • No prior radiotherapy to ≥ 25% of the bone marrow

Surgery

  • Recovered from prior surgery

Other

  • No nonsteroidal anti-inflammatory drugs or salicylates for 2 days (or 5 days for drugs with a long half-life) before, during, and for 2 days after pemetrexed disodium administration
  • Concurrent low-dose aspirin (≤ 325 mg/day) allowed

Trial locations and contacts

25 sites in 1 country.

25 sites in 1 country

United States25 sites
  • Rosenfeld Cancer Center at Abington Memorial Hospital

    Abington, Pennsylvania, 19001

  • Lurleen Wallace Comprehensive Cancer at University of Alabama-Birmingham

    Birmingham, Alabama, 35294

  • Providence Saint Joseph Medical Center - Burbank

    Burbank, California, 91505

  • Blumenthal Cancer Center at Carolinas Medical Center

    Charlotte, North Carolina, 28232-2861

  • Robert H. Lurie Comprehensive Cancer Center at Northwestern University

    Chicago, Illinois, 60611-3013

  • Charles M. Barrett Cancer Center at University Hospital

    Cincinnati, Ohio, 45267

  • Case Comprehensive Cancer Center

    Cleveland, Ohio, 44106

  • Cleveland Clinic Taussig Cancer Center

    Cleveland, Ohio, 44195

  • Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University

    Columbus, Ohio, 43210-1240

  • Riverside Methodist Hospital Cancer Care

    Columbus, Ohio, 43214-3998

  • Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas

    Dallas, Texas, 75390

  • Duke Comprehensive Cancer Center

    Durham, North Carolina, 27710

  • Hinsdale Hematology Oncology Associates

    Hinsdale, Illinois, 60521

  • Holden Comprehensive Cancer Center at University of Iowa

    Iowa City, Iowa, 52242

  • UMC Southwest Cancer and Research Center

    Lubbock, Texas, 79415-3364

  • Hillcrest Cancer Center at Hillcrest Hospital

    Mayfield Heights, Ohio, 44124

  • Lake/University Ireland Cancer Center

    Mentor, Ohio, 44060

  • Oklahoma University Cancer Institute

    Oklahoma City, Oklahoma, 73104

  • Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center

    Orange, California, 92868

  • McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center

    Reading, Pennsylvania, 19612-6052

  • St. John's Regional Health Center

    Springfield, Missouri, 65804

  • Hulston Cancer Center at Cox Medical Center South

    Springfield, Missouri, 65807

  • CCOP - Carle Cancer Center

    Urbana, Illinois, 61801

  • Cancer Institute of New Jersey at Cooper - Voorhees

    Voorhees Township, New Jersey, 08043

  • Wilson Medical Center

    Wilson, North Carolina, 27893-3428

Other trials in United States

About this study

Official title: A Phase II Trial of Pemetrexed (ALIMTA®, LY231514, IND #40061) as Salvage Therapy for Failed Low Risk Gestational Trophoblastic Tumor

RATIONALE: Drugs used in chemotherapy, such as pemetrexed disodium, work in different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: This phase II trial is studying how well pemetrexed disodium works in treating patients with recurrent or persistent low-risk gestational trophoblastic tumor after a molar pregnancy.

Read the detailed description

OBJECTIVES:

  • Determine the activity of pemetrexed disodium as salvage therapy in patients with persistent or recurrent low-risk post-molar gestational trophoblastic tumor that failed prior dactinomycin or methotrexate.
  • Determine the toxicity of this drug in these patients.

OUTLINE: This is a multicenter study.

Patients receive pemetrexed disodium IV over 10 minutes on day 1. Courses repeat every 21 days in the absence of unacceptable toxicity or disease progression or until tumor marker levels (human chorionic gonadotropin [hCG]) become normal. Patients receive 2 additional courses beyond the attainment of a normal hCG.

Beginning 7 days before and continuing until 3 weeks after the last dose of pemetrexed disodium, patients also receive oral folic acid daily and cyanocobalamin (vitamin B_12) intramuscularly every 9 weeks.

Patients are followed every 2 weeks for 2 months and then monthly for 10 months.

PROJECTED ACCRUAL: Approximately 17-55 patients will be accrued for this study within 20-50 months.

Being tested
pemetrexed disodium
Keywords
low risk metastatic gestational trophoblastic tumor, recurrent gestational trophoblastic tumor, nonmetastatic gestational trophoblastic tumor
Medical subject headings
Gestational Trophoblastic Disease

What participants receive

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

  • pemetrexed disodiumDrug

What is being measured

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

  1. Activity

  2. Toxicity

Timeline

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

  1. First posted9 Nov 2004 (estimated)
  2. Study startJul 2005
  3. Primary completion23 Jul 2007

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
Masking
None (open label)
Enrolment
55 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00096187
Sponsor's protocol ID
CDR0000390347
Other IDs
GOG-0217, GOG-UC0205, LILLY-H3E-US-JMGR
Status last verified
Apr 2018
First submitted
9 Nov 2004
Last updated
12 Apr 2018
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing pemetrexed disodium in people with Gestational Trophoblastic Tumor, run by Gynecologic Oncology Group at 25 sites 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?

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: stopped early, as of the sponsor's last update on 12 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites 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 was stopped early. Results are not available in the source record.

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?

Activity. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 12 Apr 2018.

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