Pemetrexed and Cisplatin in Treating Patients With Advanced, Persistent, or Recurrent Cervical Cancer
Recruitment status was Recruiting
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Cervical Cancer |
Drug: cisplatin Drug: pemetrexed disodium |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| 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 |
- Frequency and duration of objective response [ Designated as safety issue: No ]
- Frequency and severity of observed adverse effects [ Designated as safety issue: Yes ]
- Progression-free survival [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
| Estimated Enrollment: | 53 |
| Study Start Date: | September 2008 |
| Estimated Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
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.
Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
- 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
Contacts and Locations| United States, California | |
| USC/Norris Comprehensive Cancer Center and Hospital | Recruiting |
| Los Angeles, California, United States, 90089-9181 | |
| Contact: Clinical Trials Office - USC/Norris Comprehensive Cancer Cente 323-865-0451 | |
| Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center | Recruiting |
| Orange, California, United States, 92868 | |
| Contact: Clinical Trials Office - Chao Family Comprehensive Cancer Cent 877-UC-STUDY ucstudy@uci.edu | |
| United States, Georgia | |
| Northeast Georgia Medical Center | Recruiting |
| Gainesville, Georgia, United States, 30501 | |
| Contact: Andrew E. Green 770-535-3553 | |
| United States, Mississippi | |
| University of Mississippi Cancer Clinic | Recruiting |
| Jackson, Mississippi, United States, 39216 | |
| Contact: James T. Thigpen, MD 601-984-5590 | |
| United States, Nevada | |
| Women's Cancer Center - La Canada | Recruiting |
| Las Vegas, Nevada, United States, 89169 | |
| Contact: Nick M. Spirtos, MD 408-866-3843 | |
| United States, Ohio | |
| MetroHealth Cancer Care Center at MetroHealth Medical Center | Recruiting |
| Cleveland, Ohio, United States, 44109 | |
| Contact: Peter G. Rose, MD 216-444-1712 | |
| United States, Oklahoma | |
| Oklahoma University Cancer Institute | Recruiting |
| Oklahoma City, Oklahoma, United States, 73104 | |
| Contact: Robert S. Mannel, MD 405-271-8787 | |
| Cancer Care Associates - Saint Francis Campus | Recruiting |
| Tulsa, Oklahoma, United States, 74136-1929 | |
| Contact: Robert S. Mannel, MD 405-271-8787 | |
| United States, Texas | |
| Parkland Memorial Hospital | Recruiting |
| Dallas, Texas, United States, 75235 | |
| Contact: David S. Miller, MD 214-648-3026 | |
| Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas | Recruiting |
| Dallas, Texas, United States, 75390 | |
| Contact: Clinical Trials Office - Simmons Comprehensive Cancer Center a 866-460-4673; 214-648-7097 | |
| Lyndon B. Johnson General Hospital | Recruiting |
| Houston, Texas, United States, 77026-1967 | |
| Contact: Lois M. Ramondetta 713-745-0307 | |
| M. D. Anderson Cancer Center at University of Texas | Recruiting |
| Houston, Texas, United States, 77030-4009 | |
| Contact: Clinical Trials Office - M. D. Anderson Cancer Center at the U 713-792-3245 | |
| United States, Virginia | |
| Carilion Gynecologic Oncology Associates | Recruiting |
| Roanoke, Virginia, United States, 24016 | |
| Contact: Natalie S. Gould 540-345-8574 | |
| Study Chair: | David S. Miller, MD | Simmons Cancer Center |
| Investigator: | Bradley J. Monk, MD | Chao Family Comprehensive Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Philip J. DiSaia, Gynecologic Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00691301 History of Changes |
| Other Study ID Numbers: | CDR0000597154, GOG-0076GG |
| Study First Received: | June 4, 2008 |
| Last Updated: | March 3, 2011 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
cervical squamous cell carcinoma recurrent cervical cancer stage III cervical cancer stage IVA cervical cancer stage IVB cervical cancer |
Additional relevant MeSH terms:
|
Uterine Cervical Neoplasms Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Neoplasms Uterine Cervical Diseases Uterine Diseases Genital Diseases, Female Pemetrexed Cisplatin |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Folic Acid Antagonists Antimetabolites, Antineoplastic Antimetabolites |
ClinicalTrials.gov processed this record on May 16, 2013