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

NCT00691301 | Completed Phase 2 Results DMC

• 3 other identifiers: GOG-0076GGCDR0000597154NCI-2009-00572
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 12

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.

Conditions

Cervical Cancer

Keywords

cervical squamous cell carcinoma; recurrent cervical cancer; stage III cervical cancer; stage IVA cervical cancer; stage IVB cervical cancer

Outcome Measures

Primary Outcomes (2)

• 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.

• 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 Outcomes (2)

• Progression-free Survival

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

• Duration of Overall Survival

  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.

Study Arms (1)

Pemetrexed and cisplatin

EXPERIMENTAL

Pemtrexed plus cisplatin on day 1 every 21 days

Drug: cisplatin; Drug: pemetrexed disodium

Interventions

cisplatin DRUG

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

Pemetrexed and cisplatin

pemetrexed disodium DRUG

Pemetrexed and cisplatin

Eligibility Criteria

• Age: Up to 120 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Gynecologic Oncology Group: lead
• National Cancer Institute (NCI): collaborator

Study Sites (12)

USC/Norris Comprehensive Cancer Center and Hospital

Los Angeles, California, 90089-9181, United States

Location

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

Orange, California, 92868, United States

Location

University of Mississippi Cancer Clinic

Jackson, Mississippi, 39216, United States

Location

Women's Cancer Center - La Canada

Las Vegas, Nevada, 89169, United States

Location

MetroHealth Cancer Care Center at MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

Location

Oklahoma University Cancer Institute

Oklahoma City, Oklahoma, 73104, United States

Location

Cancer Care Associates - Saint Francis Campus

Tulsa, Oklahoma, 74136-1929, United States

Location

Parkland Memorial Hospital

Dallas, Texas, 75235, United States

Location

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

Dallas, Texas, 75390, United States

Location

Lyndon B. Johnson General Hospital

Houston, Texas, 77026-1967, United States

Location

M. D. Anderson Cancer Center at University of Texas

Houston, Texas, 77030-4009, United States

Location

Carilion Gynecologic Oncology Associates

Roanoke, Virginia, 24016, United States

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Cisplatin; Pemetrexed

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic

Results Point of Contact

• Title: Linda Gedeon for Mark Brady, PhD
• Organization: Gynecologic Oncology Group

lgedeon@gogstats.org

716-845-1169

Study Officials

• David S. Miller, MD

  Simmons Cancer Center

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2008
• First Posted: June 5, 2008
• Study Start: September 1, 2008
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: January 9, 2018
• Results First Posted: January 9, 2018

Record last verified: 2015-05

Locations

US (12)