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

Primary Purpose

Cervical Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
cisplatin
pemetrexed disodium
Sponsored by
Gynecologic Oncology Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Cancer focused on measuring cervical squamous cell carcinoma, recurrent cervical cancer, stage III cervical cancer, stage IVA cervical cancer, stage IVB cervical cancer

Eligibility Criteria

undefined - 120 Years (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • USC/Norris Comprehensive Cancer Center and Hospital
  • Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
  • University of Mississippi Cancer Clinic
  • Women's Cancer Center - La Canada
  • MetroHealth Cancer Care Center at MetroHealth Medical Center
  • Oklahoma University Cancer Institute
  • Cancer Care Associates - Saint Francis Campus
  • Parkland Memorial Hospital
  • Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
  • Lyndon B. Johnson General Hospital
  • M. D. Anderson Cancer Center at University of Texas
  • Carilion Gynecologic Oncology Associates

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pemetrexed and cisplatin

Arm Description

Pemtrexed plus cisplatin on day 1 every 21 days

Outcomes

Primary Outcome Measures

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.
Frequency and Severity of Observed Adverse Effects
All eligible and evaluable patients

Secondary Outcome Measures

Progression-free Survival
Duration of progression-free survival in months.
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.

Full Information

First Posted
June 4, 2008
Last Updated
December 12, 2017
Sponsor
Gynecologic Oncology Group
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00691301
Brief Title
Pemetrexed and Cisplatin in Treating Patients With Advanced, Persistent, or Recurrent Cervical Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gynecologic Oncology Group
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer
Keywords
cervical squamous cell carcinoma, recurrent cervical cancer, stage III cervical cancer, stage IVA cervical cancer, stage IVB cervical cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
55 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pemetrexed and cisplatin
Arm Type
Experimental
Arm Description
Pemtrexed plus cisplatin on day 1 every 21 days
Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Description
Cisplatin as an IV infusion at less than 1 mg/min over less than 4 hours at a dose of
Intervention Type
Drug
Intervention Name(s)
pemetrexed disodium
Primary Outcome Measure Information:
Title
Patients With Objective Tumor Response Rate (Complete Response [CR] or Partial Response [PR]) Using RECIST Version 1.0
Description
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.
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.
Title
Frequency and Severity of Observed Adverse Effects
Description
All eligible and evaluable patients
Time Frame
every 21 days during study treatment and up to 30 days after the last cycle of treatment.
Secondary Outcome Measure Information:
Title
Progression-free Survival
Description
Duration of progression-free survival in months.
Time Frame
From enrollment onto the study until the onset of disease progression or death, up to 5 years
Title
Duration of Overall Survival
Description
Overall survival is defined as the duration of time from study entry to time of death or the date of last contact.
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.

10. Eligibility

Sex
Female
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David S. Miller, MD
Organizational Affiliation
Simmons Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
USC/Norris Comprehensive Cancer Center and Hospital
City
Los Angeles
State/Province
California
ZIP/Postal Code
90089-9181
Country
United States
Facility Name
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
University of Mississippi Cancer Clinic
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
Women's Cancer Center - La Canada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89169
Country
United States
Facility Name
MetroHealth Cancer Care Center at MetroHealth Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States
Facility Name
Oklahoma University Cancer Institute
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Cancer Care Associates - Saint Francis Campus
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136-1929
Country
United States
Facility Name
Parkland Memorial Hospital
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Lyndon B. Johnson General Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77026-1967
Country
United States
Facility Name
M. D. Anderson Cancer Center at University of Texas
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4009
Country
United States
Facility Name
Carilion Gynecologic Oncology Associates
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24016
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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