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

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ClinicalTrials.gov Identifier: NCT00691301
Recruitment Status : Completed
First Posted : June 5, 2008
Results First Posted : January 9, 2018
Last Update Posted : January 9, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Gynecologic Oncology Group

Tracking Information
First Submitted Date  ICMJE June 4, 2008
First Posted Date  ICMJE June 5, 2008
Results First Submitted Date  ICMJE November 29, 2016
Results First Posted Date  ICMJE January 9, 2018
Last Update Posted Date January 9, 2018
Study Start Date  ICMJE September 2008
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 12, 2017)
  • 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. ]
    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.
  • Frequency and Severity of Observed Adverse Effects [ Time Frame: every 21 days during study treatment and up to 30 days after the last cycle of treatment. ]
    All eligible and evaluable patients
Original Primary Outcome Measures  ICMJE
 (submitted: June 4, 2008)
  • Frequency and duration of objective response
  • Frequency and Severity of Observed Adverse Effects
Change History Complete list of historical versions of study NCT00691301 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 12, 2017)
  • Progression-free Survival [ Time Frame: From enrollment onto the study until the onset of disease progression or death, up to 5 years ]
    Duration of progression-free survival in months.
  • Duration of Overall Survival [ Time Frame: 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. ]
    Overall survival is defined as the duration of time from study entry to time of death or the date of last contact.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 4, 2008)
  • Progression-free Survival
  • Overall survival
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pemetrexed and Cisplatin in Treating Patients With Advanced, Persistent, or Recurrent Cervical Cancer
Official Title  ICMJE 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
Brief 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. 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.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cervical Cancer
Intervention  ICMJE
  • Drug: cisplatin
    Cisplatin as an IV infusion at less than 1 mg/min over less than 4 hours at a dose of
  • Drug: pemetrexed disodium
Study Arms  ICMJE Experimental: Pemetrexed and cisplatin
Pemtrexed plus cisplatin on day 1 every 21 days
Interventions:
  • Drug: cisplatin
  • Drug: pemetrexed disodium
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 27, 2015)
55
Original Enrollment  ICMJE
 (submitted: June 4, 2008)
53
Actual Study Completion Date  ICMJE July 2014
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE up to 120 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00691301
Other Study ID Numbers  ICMJE GOG-0076GG
GOG-0076GG
CDR0000597154 ( Other Identifier: CDR )
NCI-2009-00572 ( Other Identifier: NCI )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Gynecologic Oncology Group
Study Sponsor  ICMJE Gynecologic Oncology Group
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Study Chair: David S. Miller, MD Simmons Cancer Center
PRS Account Gynecologic Oncology Group
Verification Date May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP