Clinical trial · Interventional
Pemetrexed and Cisplatin in Treating Patients With Advanced, Persistent, or Recurrent Cervical Cancer
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
NCT00691301CI-TRIAL-00031102completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cisplatin | Drug | Cisplatin | ALIAS |
| pemetrexed disodium | Drug | Pemetrexed | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Pemetrexed and cisplatin
- description
- Pemtrexed plus cisplatin on day 1 every 21 days
- interventionNames
- Drug: cisplatin
- Drug: pemetrexed disodium
Primary outcomes (2)
- measure
- Patients With Objective Tumor Response Rate (Complete Response [CR] or Partial Response [PR]) Using RECIST Version 1.0
- timeFrame
- 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.
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Maximum age
- 120 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.