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AzTrials

Cervical CancerPhase 2NCT00691301

Pemetrexed and Cisplatin in Treating Patients With Advanced, Persistent, or Recurrent Cervical Cancer

A Phase 2 study testing cisplatin and pemetrexed disodium in people with Cervical Cancer, run by Gynecologic Oncology Group at 12 sites 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

RATIONALE: Pemetrexed may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Read more about this study

Who is it for?
Ages Up to 120 years, women only
Conditions the study is for
Cervical Cancer
What is being tested?
cisplatin and pemetrexed disodium
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
55 participants
Where
12 sitesUnited States
Study dates
Sep 2008to Jul 2014
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 Up to 120 years
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically confirmed squamous or nonsquamous cell carcinoma of the cervix
  • Advanced, persistent, or recurrent disease
  • Disease not amenable to curative therapy
  • Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan
  • Must have ≥ 1 target lesion to be used to assess response
  • Tumors within a previously irradiated field will be designated as "non-target" lesions unless progression is documented or a biopsy is obtained to confirm persistence ≥ 90 days following completion of radiotherapy

PATIENT CHARACTERISTICS:

  • GOG performance status 0-2
  • Platelet count ≥ 100,000/mm^3
  • ANC ≥ 1,500/mm^3
  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • Creatinine clearance ≥ 60 mL/min
  • SGOT ≤ 2.5 times ULN (≤ 5 times ULN if due to hepatic metastases)
  • Alkaline phosphatase ≤ 2.5 times ULN (≤ 5 times ULN if due to hepatic metastases)
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Neuropathy (sensory and motor) ≤ grade 1
  • Able to take folic acid, vitamin B12, and dexamethasone according to study protocol
  • No history of other invasive malignancies within the past 5 years, except nonmelanoma skin cancer
  • No active infection requiring antibiotics with the exception of uncomplicated UTI
  • No presence of third space fluid which cannot be controlled by drainage

PRIOR CONCURRENT THERAPY:

  • Recovered from effects of recent surgery, radiotherapy, or other therapy
  • At least 1 week since prior hormonal therapy directed at the malignant tumor
  • At least 4 weeks since prior radiotherapy
  • More than 3 years since prior radiotherapy for localized cancer of the breast, head and neck, or skin and patient remains free of recurrent or metastatic disease
  • No prior radiotherapy to any portion of the abdominal cavity or pelvis except for the treatment of cervical cancer
  • No prior radiotherapy to more than 25% of marrow-bearing areas
  • No prior cancer treatment that contraindicates study treatment
  • No prior cytotoxic drugs for advanced or recurrent carcinoma of the cervix
  • Prior cisplatin as a radiosensitizer for primary treatment of disease allowed
  • No nonsteroidal anti-inflammatory drugs (NSAIDs) or salicylates 2-5 days before, during, or for 2 days after receiving pemetrexed disodium
  • No NSAIDS with a long half-life (e.g., naproxen, piroxicam, diflunisal, or nabumetone) 5 days before, during, and for 2 days after receiving pemetrexed disodium
  • Concurrent hormone replacement therapy is permitted
  • Concurrent daily low-dose acetylsalicylic acid therapy (≤ 325 mg/day) allowed
  • Concurrent use of acetylsalicylic acid (up to 1.3 g/day) allowed

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

United States12 sites

  • MetroHealth Cancer Care Center at MetroHealth Medical Center

    Cleveland, Ohio, 44109

  • Parkland Memorial Hospital

    Dallas, Texas, 75235

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

    Dallas, Texas, 75390

  • Lyndon B. Johnson General Hospital

    Houston, Texas, 77026-1967

  • M. D. Anderson Cancer Center at University of Texas

    Houston, Texas, 77030-4009

  • University of Mississippi Cancer Clinic

    Jackson, Mississippi, 39216

  • Women's Cancer Center - La Canada

    Las Vegas, Nevada, 89169

  • USC/Norris Comprehensive Cancer Center and Hospital

    Los Angeles, California, 90089-9181

  • Oklahoma University Cancer Institute

    Oklahoma City, Oklahoma, 73104

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

    Orange, California, 92868

  • Carilion Gynecologic Oncology Associates

    Roanoke, Virginia, 24016

  • Cancer Care Associates - Saint Francis Campus

    Tulsa, Oklahoma, 74136-1929

Other trials in United States

About this study

Official title: A Limited Access Phase II Trial of Pemetrexed (Alimta, LY231514) (NSC #698037) in Combination With Cisplatin (NSC #119875) in the Treatment of Advanced, Persistent, or Recurrent Carcinoma of the Cervix

RATIONALE: Pemetrexed may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving pemetrexed together with cisplatin may kill more tumor cells.

PURPOSE: This phase II trial is studying the side effects of giving pemetrexed together with cisplatin and to see how well it works in treating patients with advanced, persistent, or recurrent cervical cancer.

Read the detailed description

OBJECTIVES:

Primary

  • To estimate the antitumor activity of pemetrexed disodium and cisplatin with objective tumor response (partial and complete response) in patients with advanced, persistent, or recurrent carcinoma of the cervix.
  • To determine the nature and degree of toxicity of this regimen in these patients.

Secondary

  • To determine the effects of this regimen on progression-free survival and overall survival.

OUTLINE: This is a multicenter study. Patients are stratified according to prior cisplatin therapy as a radiosensitizer (yes vs no).

Patients receive pemetrexed disodium IV over 10 minutes and cisplatin IV over 1-4 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 3 years.

Conditions
Cervical Cancer
Being tested
cisplatin, pemetrexed disodium
Keywords
cervical squamous cell carcinoma, recurrent cervical cancer, stage III cervical cancer, stage IVA cervical cancer, stage IVB cervical cancer
Medical subject headings
Uterine Cervical Neoplasms

What participants receive

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

  • cisplatinDrug

    Cisplatin as an IV infusion at less than 1 mg/min over less than 4 hours at a dose of

  • pemetrexed disodiumDrug

Study groups in NCT00691301
Study groupRoleWhat they receive
Pemetrexed and cisplatinExperimentalPemtrexed plus cisplatin on day 1 every 21 days
Receives: Drug: cisplatin; Drug: pemetrexed disodium

What is being measured

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

  1. Patients With Objective Tumor Response Rate (Complete Response [CR] or Partial Response [PR]) Using RECIST Version 1.0

    RECIST 1.0 defines complete response as the disappearance of all target lesions and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial response is defined as at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of non-target lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% decrease in the LD is required. These patients will have their response classified according to the definitions stated above. Complete and partial responses are included in the objective tumor response rate.

    Measured: CT scan or MRI if used to follow lesion for measurable disease every other cycle until disease progression or study withdrawal; and at any other time if clinically indicated, up to 5 years.

  2. Frequency and Severity of Observed Adverse Effects

    All eligible and evaluable patients

    Measured: every 21 days during study treatment and up to 30 days after the last cycle of treatment.

Secondary outcomes (2)

  1. Progression-free Survival

    Duration of progression-free survival in months.

    Measured: From enrollment onto the study until the onset of disease progression or death, up to 5 years

  2. Duration of Overall Survival

    Overall survival is defined as the duration of time from study entry to time of death or the date of last contact.

    Measured: Every cycle during treatment, then every 3 months for the first 2 years, then every six months for the next three years and then annually, up to 5 years.

Timeline

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

  1. First posted5 Jun 2008 (estimated)
  2. Study startSep 2008
  3. Primary completionJul 2014
  4. Study completionJul 2014

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
55 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00691301
Sponsor's protocol ID
GOG-0076GG
Other IDs
GOG-0076GG, CDR0000597154, NCI-2009-00572
Status last verified
May 2015
First submitted
4 Jun 2008
Last updated
9 Jan 2018
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing cisplatin and pemetrexed disodium in people with Cervical Cancer, run by Gynecologic Oncology Group at 12 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: finished, as of the sponsor's last update on 9 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 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?

Yes. Results are posted in the registry (first posted 9 Jan 2018). 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?

Patients With Objective Tumor Response Rate (Complete Response [CR] or Partial Response [PR]) Using RECIST Version 1.0 (time frame: CT scan or MRI if used to follow lesion for measurable disease every other cycle until disease progression or study withdrawal; and at any other time if clinically indicated, up to 5 years.). 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?

On the ClinicalTrials.gov record for NCT00691301.

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 Jan 2018.

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