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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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00691301
Enrollment
55
Registered
2008-06-05
Start date
2008-09-30
Completion date
2014-07-31
Last updated
2018-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Cancer

Keywords

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

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.

Interventions

DRUGcisplatin

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

DRUGpemetrexed disodium

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Gynecologic Oncology Group
Lead SponsorNETWORK

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
No minimum to 120 Years
Healthy volunteers
No

Inclusion 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

Design outcomes

Primary

MeasureTime frameDescription
Patients With Objective Tumor Response Rate (Complete Response [CR] or Partial Response [PR]) Using RECIST Version 1.0CT 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.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 Effectsevery 21 days during study treatment and up to 30 days after the last cycle of treatment.All eligible and evaluable patients

Secondary

MeasureTime frameDescription
Progression-free SurvivalFrom enrollment onto the study until the onset of disease progression or death, up to 5 yearsDuration of progression-free survival in months.
Duration of Overall SurvivalEvery 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.Overall survival is defined as the duration of time from study entry to time of death or the date of last contact.

Countries

United States

Participant flow

Participants by arm

ArmCount
Pemetrexed and Cisplatin
Pemtrexed plus cisplatin on day 1 every 21 days cisplatin: Cisplatin as an IV infusion at less than 1 mg/min over less than 4 hours at a dose of pemetrexed disodium
54
Total54

Withdrawals & dropouts

PeriodReasonFG000
Overall StudyAdverse Event10
Overall StudyConcurrent illness2
Overall StudyDeath2
Overall StudyDid not initiate study treatment1
Overall StudyLack of Efficacy32
Overall Studyother reason3
Overall StudyWithdrawal by Subject4

Baseline characteristics

CharacteristicPemetrexed and Cisplatin
Age, Customized
20-29 years
3 participants
Age, Customized
30-39 years
10 participants
Age, Customized
40-49 years
23 participants
Age, Customized
50-59 years
15 participants
Age, Customized
>60 years
3 participants
Ethnicity (NIH/OMB)
Hispanic or Latino
13 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
41 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants
Race (NIH/OMB)
Asian
2 Participants
Race (NIH/OMB)
Black or African American
9 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
13 Participants
Race (NIH/OMB)
White
29 Participants
Region of Enrollment
United States
54 participants
Sex: Female, Male
Female
54 Participants
Sex: Female, Male
Male
0 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
54 / 54
serious
Total, serious adverse events
23 / 54

Outcome results

Primary

Frequency and Severity of Observed Adverse Effects

All eligible and evaluable patients

Time frame: every 21 days during study treatment and up to 30 days after the last cycle of treatment.

Population: All eligible and evaluable patients.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Pemetrexed and CisplatinFrequency and Severity of Observed Adverse EffectsLeukopenia16 Participants
Pemetrexed and CisplatinFrequency and Severity of Observed Adverse EffectsThrombocytopenia32 Participants
Pemetrexed and CisplatinFrequency and Severity of Observed Adverse EffectsNeutropenia20 Participants
Pemetrexed and CisplatinFrequency and Severity of Observed Adverse EffectsAnemia2 Participants
Pemetrexed and CisplatinFrequency and Severity of Observed Adverse EffectsOther hematologic49 Participants
Pemetrexed and CisplatinFrequency and Severity of Observed Adverse EffectsAllergy/immunology49 Participants
Pemetrexed and CisplatinFrequency and Severity of Observed Adverse EffectsAuditory/ear39 Participants
Pemetrexed and CisplatinFrequency and Severity of Observed Adverse EffectsCardiac47 Participants
Pemetrexed and CisplatinFrequency and Severity of Observed Adverse EffectsCoagulation53 Participants
Pemetrexed and CisplatinFrequency and Severity of Observed Adverse EffectsConstitutional6 Participants
Pemetrexed and CisplatinFrequency and Severity of Observed Adverse EffectsDermatologic24 Participants
Pemetrexed and CisplatinFrequency and Severity of Observed Adverse EffectsEndocrine53 Participants
Pemetrexed and CisplatinFrequency and Severity of Observed Adverse EffectsNausea7 Participants
Pemetrexed and CisplatinFrequency and Severity of Observed Adverse EffectsVomiting19 Participants
Pemetrexed and CisplatinFrequency and Severity of Observed Adverse EffectsGastrointestinal4 Participants
Pemetrexed and CisplatinFrequency and Severity of Observed Adverse EffectsGenitourinary/renal43 Participants
Pemetrexed and CisplatinFrequency and Severity of Observed Adverse EffectsHemorrhage44 Participants
Pemetrexed and CisplatinFrequency and Severity of Observed Adverse EffectsInfection37 Participants
Pemetrexed and CisplatinFrequency and Severity of Observed Adverse EffectsLymphatics42 Participants
Pemetrexed and CisplatinFrequency and Severity of Observed Adverse EffectsMetabolic10 Participants
Pemetrexed and CisplatinFrequency and Severity of Observed Adverse EffectsMusculoskeletal50 Participants
Pemetrexed and CisplatinFrequency and Severity of Observed Adverse EffectsNeurosensory31 Participants
Pemetrexed and CisplatinFrequency and Severity of Observed Adverse EffectsOther neurological42 Participants
Pemetrexed and CisplatinFrequency and Severity of Observed Adverse EffectsOcular/visual44 Participants
Pemetrexed and CisplatinFrequency and Severity of Observed Adverse EffectsPain18 Participants
Pemetrexed and CisplatinFrequency and Severity of Observed Adverse EffectsPulmonary37 Participants
Pemetrexed and CisplatinFrequency and Severity of Observed Adverse EffectsSexual/reproductive53 Participants
Pemetrexed and CisplatinFrequency and Severity of Observed Adverse EffectsSyndromes52 Participants
Pemetrexed and CisplatinFrequency and Severity of Observed Adverse EffectsVascular50 Participants
Grade 1 (CTCAE v 3.0)Frequency and Severity of Observed Adverse EffectsGastrointestinal15 Participants
Grade 1 (CTCAE v 3.0)Frequency and Severity of Observed Adverse EffectsVomiting11 Participants
Grade 1 (CTCAE v 3.0)Frequency and Severity of Observed Adverse EffectsVascular0 Participants
Grade 1 (CTCAE v 3.0)Frequency and Severity of Observed Adverse EffectsDermatologic20 Participants
Grade 1 (CTCAE v 3.0)Frequency and Severity of Observed Adverse EffectsCoagulation0 Participants
Grade 1 (CTCAE v 3.0)Frequency and Severity of Observed Adverse EffectsNausea19 Participants
Grade 1 (CTCAE v 3.0)Frequency and Severity of Observed Adverse EffectsSexual/reproductive1 Participants
Grade 1 (CTCAE v 3.0)Frequency and Severity of Observed Adverse EffectsPulmonary9 Participants
Grade 1 (CTCAE v 3.0)Frequency and Severity of Observed Adverse EffectsAuditory/ear0 Participants
Grade 1 (CTCAE v 3.0)Frequency and Severity of Observed Adverse EffectsEndocrine1 Participants
Grade 1 (CTCAE v 3.0)Frequency and Severity of Observed Adverse EffectsNeurosensory15 Participants
Grade 1 (CTCAE v 3.0)Frequency and Severity of Observed Adverse EffectsMusculoskeletal3 Participants
Grade 1 (CTCAE v 3.0)Frequency and Severity of Observed Adverse EffectsPain11 Participants
Grade 1 (CTCAE v 3.0)Frequency and Severity of Observed Adverse EffectsNeutropenia5 Participants
Grade 1 (CTCAE v 3.0)Frequency and Severity of Observed Adverse EffectsOcular/visual6 Participants
Grade 1 (CTCAE v 3.0)Frequency and Severity of Observed Adverse EffectsMetabolic19 Participants
Grade 1 (CTCAE v 3.0)Frequency and Severity of Observed Adverse EffectsLymphatics5 Participants
Grade 1 (CTCAE v 3.0)Frequency and Severity of Observed Adverse EffectsConstitutional12 Participants
Grade 1 (CTCAE v 3.0)Frequency and Severity of Observed Adverse EffectsSyndromes1 Participants
Grade 1 (CTCAE v 3.0)Frequency and Severity of Observed Adverse EffectsAnemia17 Participants
Grade 1 (CTCAE v 3.0)Frequency and Severity of Observed Adverse EffectsOther neurological8 Participants
Grade 1 (CTCAE v 3.0)Frequency and Severity of Observed Adverse EffectsInfection0 Participants
Grade 1 (CTCAE v 3.0)Frequency and Severity of Observed Adverse EffectsCardiac5 Participants
Grade 1 (CTCAE v 3.0)Frequency and Severity of Observed Adverse EffectsLeukopenia8 Participants
Grade 1 (CTCAE v 3.0)Frequency and Severity of Observed Adverse EffectsHemorrhage7 Participants
Grade 1 (CTCAE v 3.0)Frequency and Severity of Observed Adverse EffectsOther hematologic0 Participants
Grade 1 (CTCAE v 3.0)Frequency and Severity of Observed Adverse EffectsThrombocytopenia11 Participants
Grade 1 (CTCAE v 3.0)Frequency and Severity of Observed Adverse EffectsAllergy/immunology3 Participants
Grade 1 (CTCAE v 3.0)Frequency and Severity of Observed Adverse EffectsGenitourinary/renal6 Participants
Grade 2 (CTCAE v 3.0)Frequency and Severity of Observed Adverse EffectsMetabolic10 Participants
Grade 2 (CTCAE v 3.0)Frequency and Severity of Observed Adverse EffectsLeukopenia15 Participants
Grade 2 (CTCAE v 3.0)Frequency and Severity of Observed Adverse EffectsPain13 Participants
Grade 2 (CTCAE v 3.0)Frequency and Severity of Observed Adverse EffectsThrombocytopenia5 Participants
Grade 2 (CTCAE v 3.0)Frequency and Severity of Observed Adverse EffectsNeutropenia10 Participants
Grade 2 (CTCAE v 3.0)Frequency and Severity of Observed Adverse EffectsAnemia22 Participants
Grade 2 (CTCAE v 3.0)Frequency and Severity of Observed Adverse EffectsConstitutional23 Participants
Grade 2 (CTCAE v 3.0)Frequency and Severity of Observed Adverse EffectsOther hematologic3 Participants
Grade 2 (CTCAE v 3.0)Frequency and Severity of Observed Adverse EffectsVascular3 Participants
Grade 2 (CTCAE v 3.0)Frequency and Severity of Observed Adverse EffectsDermatologic9 Participants
Grade 2 (CTCAE v 3.0)Frequency and Severity of Observed Adverse EffectsEndocrine0 Participants
Grade 2 (CTCAE v 3.0)Frequency and Severity of Observed Adverse EffectsNausea22 Participants
Grade 2 (CTCAE v 3.0)Frequency and Severity of Observed Adverse EffectsAuditory/ear14 Participants
Grade 2 (CTCAE v 3.0)Frequency and Severity of Observed Adverse EffectsSexual/reproductive0 Participants
Grade 2 (CTCAE v 3.0)Frequency and Severity of Observed Adverse EffectsVomiting17 Participants
Grade 2 (CTCAE v 3.0)Frequency and Severity of Observed Adverse EffectsGastrointestinal24 Participants
Grade 2 (CTCAE v 3.0)Frequency and Severity of Observed Adverse EffectsGenitourinary/renal4 Participants
Grade 2 (CTCAE v 3.0)Frequency and Severity of Observed Adverse EffectsPulmonary6 Participants
Grade 2 (CTCAE v 3.0)Frequency and Severity of Observed Adverse EffectsHemorrhage0 Participants
Grade 2 (CTCAE v 3.0)Frequency and Severity of Observed Adverse EffectsInfection11 Participants
Grade 2 (CTCAE v 3.0)Frequency and Severity of Observed Adverse EffectsCardiac2 Participants
Grade 2 (CTCAE v 3.0)Frequency and Severity of Observed Adverse EffectsLymphatics7 Participants
Grade 2 (CTCAE v 3.0)Frequency and Severity of Observed Adverse EffectsSyndromes1 Participants
Grade 2 (CTCAE v 3.0)Frequency and Severity of Observed Adverse EffectsMusculoskeletal0 Participants
Grade 2 (CTCAE v 3.0)Frequency and Severity of Observed Adverse EffectsAllergy/immunology0 Participants
Grade 2 (CTCAE v 3.0)Frequency and Severity of Observed Adverse EffectsNeurosensory6 Participants
Grade 2 (CTCAE v 3.0)Frequency and Severity of Observed Adverse EffectsOther neurological3 Participants
Grade 2 (CTCAE v 3.0)Frequency and Severity of Observed Adverse EffectsCoagulation0 Participants
Grade 2 (CTCAE v 3.0)Frequency and Severity of Observed Adverse EffectsOcular/visual2 Participants
Grade 3 (CTCAE v 3.0)Frequency and Severity of Observed Adverse EffectsPain12 Participants
Grade 3 (CTCAE v 3.0)Frequency and Severity of Observed Adverse EffectsMetabolic10 Participants
Grade 3 (CTCAE v 3.0)Frequency and Severity of Observed Adverse EffectsAnemia6 Participants
Grade 3 (CTCAE v 3.0)Frequency and Severity of Observed Adverse EffectsOther neurological1 Participants
Grade 3 (CTCAE v 3.0)Frequency and Severity of Observed Adverse EffectsSyndromes0 Participants
Grade 3 (CTCAE v 3.0)Frequency and Severity of Observed Adverse EffectsInfection6 Participants
Grade 3 (CTCAE v 3.0)Frequency and Severity of Observed Adverse EffectsConstitutional12 Participants
Grade 3 (CTCAE v 3.0)Frequency and Severity of Observed Adverse EffectsMusculoskeletal1 Participants
Grade 3 (CTCAE v 3.0)Frequency and Severity of Observed Adverse EffectsGenitourinary/renal1 Participants
Grade 3 (CTCAE v 3.0)Frequency and Severity of Observed Adverse EffectsLeukopenia12 Participants
Grade 3 (CTCAE v 3.0)Frequency and Severity of Observed Adverse EffectsHemorrhage2 Participants
Grade 3 (CTCAE v 3.0)Frequency and Severity of Observed Adverse EffectsEndocrine0 Participants
Grade 3 (CTCAE v 3.0)Frequency and Severity of Observed Adverse EffectsThrombocytopenia3 Participants
Grade 3 (CTCAE v 3.0)Frequency and Severity of Observed Adverse EffectsVascular1 Participants
Grade 3 (CTCAE v 3.0)Frequency and Severity of Observed Adverse EffectsOther hematologic1 Participants
Grade 3 (CTCAE v 3.0)Frequency and Severity of Observed Adverse EffectsDermatologic1 Participants
Grade 3 (CTCAE v 3.0)Frequency and Severity of Observed Adverse EffectsLymphatics0 Participants
Grade 3 (CTCAE v 3.0)Frequency and Severity of Observed Adverse EffectsNausea6 Participants
Grade 3 (CTCAE v 3.0)Frequency and Severity of Observed Adverse EffectsAllergy/immunology1 Participants
Grade 3 (CTCAE v 3.0)Frequency and Severity of Observed Adverse EffectsOcular/visual2 Participants
Grade 3 (CTCAE v 3.0)Frequency and Severity of Observed Adverse EffectsNeurosensory2 Participants
Grade 3 (CTCAE v 3.0)Frequency and Severity of Observed Adverse EffectsGastrointestinal10 Participants
Grade 3 (CTCAE v 3.0)Frequency and Severity of Observed Adverse EffectsCardiac0 Participants
Grade 3 (CTCAE v 3.0)Frequency and Severity of Observed Adverse EffectsVomiting7 Participants
Grade 3 (CTCAE v 3.0)Frequency and Severity of Observed Adverse EffectsCoagulation1 Participants
Grade 3 (CTCAE v 3.0)Frequency and Severity of Observed Adverse EffectsAuditory/ear1 Participants
Grade 3 (CTCAE v 3.0)Frequency and Severity of Observed Adverse EffectsSexual/reproductive0 Participants
Grade 3 (CTCAE v 3.0)Frequency and Severity of Observed Adverse EffectsNeutropenia12 Participants
Grade 3 (CTCAE v 3.0)Frequency and Severity of Observed Adverse EffectsPulmonary2 Participants
Grade 4 (CTCAE v 3.0)Frequency and Severity of Observed Adverse EffectsAllergy/immunology1 Participants
Grade 4 (CTCAE v 3.0)Frequency and Severity of Observed Adverse EffectsGastrointestinal1 Participants
Grade 4 (CTCAE v 3.0)Frequency and Severity of Observed Adverse EffectsAuditory/ear0 Participants
Grade 4 (CTCAE v 3.0)Frequency and Severity of Observed Adverse EffectsSexual/reproductive0 Participants
Grade 4 (CTCAE v 3.0)Frequency and Severity of Observed Adverse EffectsOther hematologic1 Participants
Grade 4 (CTCAE v 3.0)Frequency and Severity of Observed Adverse EffectsGenitourinary/renal0 Participants
Grade 4 (CTCAE v 3.0)Frequency and Severity of Observed Adverse EffectsOcular/visual0 Participants
Grade 4 (CTCAE v 3.0)Frequency and Severity of Observed Adverse EffectsHemorrhage1 Participants
Grade 4 (CTCAE v 3.0)Frequency and Severity of Observed Adverse EffectsAnemia7 Participants
Grade 4 (CTCAE v 3.0)Frequency and Severity of Observed Adverse EffectsVascular0 Participants
Grade 4 (CTCAE v 3.0)Frequency and Severity of Observed Adverse EffectsInfection0 Participants
Grade 4 (CTCAE v 3.0)Frequency and Severity of Observed Adverse EffectsOther neurological0 Participants
Grade 4 (CTCAE v 3.0)Frequency and Severity of Observed Adverse EffectsPain0 Participants
Grade 4 (CTCAE v 3.0)Frequency and Severity of Observed Adverse EffectsNeutropenia7 Participants
Grade 4 (CTCAE v 3.0)Frequency and Severity of Observed Adverse EffectsCoagulation0 Participants
Grade 4 (CTCAE v 3.0)Frequency and Severity of Observed Adverse EffectsLymphatics0 Participants
Grade 4 (CTCAE v 3.0)Frequency and Severity of Observed Adverse EffectsMetabolic5 Participants
Grade 4 (CTCAE v 3.0)Frequency and Severity of Observed Adverse EffectsCardiac0 Participants
Grade 4 (CTCAE v 3.0)Frequency and Severity of Observed Adverse EffectsPulmonary0 Participants
Grade 4 (CTCAE v 3.0)Frequency and Severity of Observed Adverse EffectsLeukopenia3 Participants
Grade 4 (CTCAE v 3.0)Frequency and Severity of Observed Adverse EffectsMusculoskeletal0 Participants
Grade 4 (CTCAE v 3.0)Frequency and Severity of Observed Adverse EffectsSyndromes0 Participants
Grade 4 (CTCAE v 3.0)Frequency and Severity of Observed Adverse EffectsEndocrine0 Participants
Grade 4 (CTCAE v 3.0)Frequency and Severity of Observed Adverse EffectsDermatologic0 Participants
Grade 4 (CTCAE v 3.0)Frequency and Severity of Observed Adverse EffectsThrombocytopenia3 Participants
Grade 4 (CTCAE v 3.0)Frequency and Severity of Observed Adverse EffectsNausea0 Participants
Grade 4 (CTCAE v 3.0)Frequency and Severity of Observed Adverse EffectsNeurosensory0 Participants
Grade 4 (CTCAE v 3.0)Frequency and Severity of Observed Adverse EffectsVomiting0 Participants
Grade 4 (CTCAE v 3.0)Frequency and Severity of Observed Adverse EffectsConstitutional1 Participants
Grade 5 (CTCAE v 3.0)Frequency and Severity of Observed Adverse EffectsMetabolic0 Participants
Grade 5 (CTCAE v 3.0)Frequency and Severity of Observed Adverse EffectsAllergy/immunology0 Participants
Grade 5 (CTCAE v 3.0)Frequency and Severity of Observed Adverse EffectsAuditory/ear0 Participants
Grade 5 (CTCAE v 3.0)Frequency and Severity of Observed Adverse EffectsCardiac0 Participants
Grade 5 (CTCAE v 3.0)Frequency and Severity of Observed Adverse EffectsCoagulation0 Participants
Grade 5 (CTCAE v 3.0)Frequency and Severity of Observed Adverse EffectsConstitutional0 Participants
Grade 5 (CTCAE v 3.0)Frequency and Severity of Observed Adverse EffectsPulmonary0 Participants
Grade 5 (CTCAE v 3.0)Frequency and Severity of Observed Adverse EffectsDermatologic0 Participants
Grade 5 (CTCAE v 3.0)Frequency and Severity of Observed Adverse EffectsEndocrine0 Participants
Grade 5 (CTCAE v 3.0)Frequency and Severity of Observed Adverse EffectsNausea0 Participants
Grade 5 (CTCAE v 3.0)Frequency and Severity of Observed Adverse EffectsVomiting0 Participants
Grade 5 (CTCAE v 3.0)Frequency and Severity of Observed Adverse EffectsGastrointestinal0 Participants
Grade 5 (CTCAE v 3.0)Frequency and Severity of Observed Adverse EffectsGenitourinary/renal0 Participants
Grade 5 (CTCAE v 3.0)Frequency and Severity of Observed Adverse EffectsSexual/reproductive0 Participants
Grade 5 (CTCAE v 3.0)Frequency and Severity of Observed Adverse EffectsHemorrhage0 Participants
Grade 5 (CTCAE v 3.0)Frequency and Severity of Observed Adverse EffectsInfection0 Participants
Grade 5 (CTCAE v 3.0)Frequency and Severity of Observed Adverse EffectsLymphatics0 Participants
Grade 5 (CTCAE v 3.0)Frequency and Severity of Observed Adverse EffectsOther hematologic0 Participants
Grade 5 (CTCAE v 3.0)Frequency and Severity of Observed Adverse EffectsMusculoskeletal0 Participants
Grade 5 (CTCAE v 3.0)Frequency and Severity of Observed Adverse EffectsNeurosensory0 Participants
Grade 5 (CTCAE v 3.0)Frequency and Severity of Observed Adverse EffectsSyndromes0 Participants
Grade 5 (CTCAE v 3.0)Frequency and Severity of Observed Adverse EffectsOther neurological0 Participants
Grade 5 (CTCAE v 3.0)Frequency and Severity of Observed Adverse EffectsVascular0 Participants
Grade 5 (CTCAE v 3.0)Frequency and Severity of Observed Adverse EffectsOcular/visual0 Participants
Grade 5 (CTCAE v 3.0)Frequency and Severity of Observed Adverse EffectsLeukopenia0 Participants
Grade 5 (CTCAE v 3.0)Frequency and Severity of Observed Adverse EffectsThrombocytopenia0 Participants
Grade 5 (CTCAE v 3.0)Frequency and Severity of Observed Adverse EffectsNeutropenia0 Participants
Grade 5 (CTCAE v 3.0)Frequency and Severity of Observed Adverse EffectsAnemia0 Participants
Grade 5 (CTCAE v 3.0)Frequency and Severity of Observed Adverse EffectsPain0 Participants
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.

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.

Population: Individuals who initiated study treatment

ArmMeasureGroupValue (NUMBER)
Pemetrexed and CisplatinPatients With Objective Tumor Response Rate (Complete Response [CR] or Partial Response [PR]) Using RECIST Version 1.0Complete Response1 participants
Pemetrexed and CisplatinPatients With Objective Tumor Response Rate (Complete Response [CR] or Partial Response [PR]) Using RECIST Version 1.0Partial Response16 participants
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.

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.

Population: Eligible and treated patients

ArmMeasureValue (MEDIAN)
Pemetrexed and CisplatinDuration of Overall Survival12.3 months
Secondary

Progression-free Survival

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

Population: Individuals who initiated study treatment

ArmMeasureValue (MEDIAN)
Pemetrexed and CisplatinProgression-free Survival5.6 months

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026