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

Cervical Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00691301
• Other study ID #: GOG-0076GG
• Secondary ID: GOG-0076GGCDR000
• Status: Completed
• Phase: Phase 2
• First received: June 4, 2008
• Last updated: December 12, 2017
• Start date: September 2008
• Est. completion date: July 2014

Study information

• Verified date: May 2015
• Source: Gynecologic Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

Drug:
• cisplatin
Cisplatin as an IV infusion at less than 1 mg/min over less than 4 hours at a dose of
• pemetrexed disodium

Locations

Country	Name	City	State
United States	MetroHealth Cancer Care Center at MetroHealth Medical Center	Cleveland	Ohio
United States	Parkland Memorial Hospital	Dallas	Texas
United States	Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas	Dallas	Texas
United States	Lyndon B. Johnson General Hospital	Houston	Texas
United States	M. D. Anderson Cancer Center at University of Texas	Houston	Texas
United States	University of Mississippi Cancer Clinic	Jackson	Mississippi
United States	Women's Cancer Center - La Canada	Las Vegas	Nevada
United States	USC/Norris Comprehensive Cancer Center and Hospital	Los Angeles	California
United States	Oklahoma University Cancer Institute	Oklahoma City	Oklahoma
United States	Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center	Orange	California
United States	Carilion Gynecologic Oncology Associates	Roanoke	Virginia
United States	Cancer Care Associates - Saint Francis Campus	Tulsa	Oklahoma

Sponsors (2)

Lead Sponsor	Collaborator
Gynecologic Oncology Group	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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.
Primary	Frequency and Severity of Observed Adverse Effects	All eligible and evaluable patients	every 21 days during study treatment and up to 30 days after the last cycle of treatment.
Secondary	Progression-free Survival	Duration of progression-free survival in months.	From enrollment onto the study until the onset of disease progression or death, up to 5 years
Secondary	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.	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.