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A Phase II Study of Pemetrexed and Carboplatin in the Treatment of Esophageal Cancer

A Phase II Study of Pemetrexed and Carboplatin in the Treatment of Esophageal Cancer

Status
Terminated
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00383266
Enrollment
9
Registered
2006-10-03
Start date
2006-10-31
Completion date
2010-06-30
Last updated
2016-01-11

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

Conditions

Esophageal Neoplasms

Brief summary

This is a study of an investigational agent, pemetrexed, in combination with a standard chemotherapy drug, carboplatin, for treatment of patients with metastatic esophageal cancer.

Interventions

DRUGPemetrexed
DRUGCarboplatin

Sponsors

Eli Lilly and Company
CollaboratorINDUSTRY
Washington University School of Medicine
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients must have a histologically or cytologically proven metastatic or recurrent esophageal cancer. Both adenocarcinoma and squamous carcinoma are eligible for the study. Patients with small cell carcinoma or sarcoma of the esophagus are not eligible for the study. * Patients may have had no prior chemotherapy treatment for metastatic esophageal cancer. Patients may have had chemotherapy with 5-FU combined with definitive radiotherapy for curative intent in the adjuvant, neoadjuvant, or definite setting for locally advanced esophageal cancer, if no less than one year prior to trial enrollment. Patients may not have received pemetrexed in the past. * Patients who have had radiotherapy for esophageal cancer must have completed radiotherapy at least four weeks prior to entry in the study. * Patients need to have measurable disease. * Lesions that are not considered measurable include the following: * Bone lesions * Brain metastases or leptomeningeal disease * Ascites * Pleural/pericardial effusion * Abdominal masses that are not confirmed and followed by imaging techniques * Cystic lesions * Tumor lesions situated in a previously irradiated area * ECOG) performance status of 0-2. * Life expectancy of \>=12 weeks. * Patients must have adequate bone marrow function defined as: white blood cells (WBC) \>= 3000/mm\^3, absolute neutrophil count (ANC) \>= 1,500/mm\^3, hemoglobin \>= 9.0 g/dL, and platelet count \>= 100,000/mm\^3. * Patients must have adequate liver function defined as: Bilirubin \<= 1.5 x institutional normal and ALT/AST \< 3 x institutional normal. * Patients must have adequate renal function defined as: serum creatinine \<= 3.0 mg/dL and creatinine clearance \>= 45 mL/min. * Radiation therapy for brain metastases should be completed at least four weeks prior to enrollment to this protocol. * Patients must have recovered from uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or uncontrolled symptomatic cardiac arrhythmia. * Patients must be able to be compliant with premedications of dexamethasone, folic acid, and vitamin B12. * For all sexually active women of child-bearing age, the use of adequate contraception (hormonal or barrier method of birth control) will be required prior to study entry and for the duration of study participation. * Age \>= 18 years. * Written consent. * Ibuprofen (400 mg qid) can be administered with Alimta in patients with normal renal function (creatinine clearance \> 80 mL/min

Exclusion criteria

* Patients with third-space fluid (pleural effusions, ascites, etc.) uncontrolled by drainage. * Pregnant or nursing females * Patients who have had pre-existing neuropathy greater than or equal to grade 2. * Patients with known active CNS metastases.

Design outcomes

Primary

MeasureTime frameDescription
Overall Response Rate (ORR)Until patient progresses or dies (median follow-up 293 days -- range (63-632 days)* Overall response rate = complete response (CR) + partial response (PR) using RECIST. * CR=disappearance of all target lesions and disappearance of all non-target lesions and normalization of tumor marker level * PR=at least a 30% decrease in the sum of the longest diameter (LD) of the target lesions taking as reference the baseline sum LD

Secondary

MeasureTime frameDescription
Time to Disease ProgressionUntil patient progresses (median follow-up 293 days -- range (63-632 days)-Progressive disease=at least a 20% increase in the sum of the LD of the target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions
Overall Survival Rate1 year—
Toxicities30 days following completion of treatment (maximum number of cycles = 6)—
Overall Survival (OS)Until patient's death (median follow-up 293 days -- range (63-632 days))OS is defined as the time from initiation of treatment to the date of any reason death while those living subjects will be censored at the last assessment date.

Countries

United States

Participant flow

Recruitment details

The study opened to participant enrollment on 10/11/2006 and closed to participant enrollment on 11/12/2009.

Participants by arm

ArmCount
Pemetrexed + Carboplatin
* Pemetrexed 500 mg/m2 IV over 10 minutes * Carboplatin AUC 5 IV over 30 minutes on day 1 of each cycle * Each cycle will last 21 days.
9
Total9

Baseline characteristics

CharacteristicPemetrexed + Carboplatin
Age, Continuous62 years
Region of Enrollment
United States
9 participants
Sex: Female, Male
Female
2 Participants
Sex: Female, Male
Male
7 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
9 / 9
serious
Total, serious adverse events
2 / 9

Outcome results

Primary

Overall Response Rate (ORR)

* Overall response rate = complete response (CR) + partial response (PR) using RECIST. * CR=disappearance of all target lesions and disappearance of all non-target lesions and normalization of tumor marker level * PR=at least a 30% decrease in the sum of the longest diameter (LD) of the target lesions taking as reference the baseline sum LD

Time frame: Until patient progresses or dies (median follow-up 293 days -- range (63-632 days)

ArmMeasureGroupValue (NUMBER)
Pemetrexed + CarboplatinOverall Response Rate (ORR)Complete response0 percentage of participants
Pemetrexed + CarboplatinOverall Response Rate (ORR)Partial response33 percentage of participants
Secondary

Overall Survival (OS)

OS is defined as the time from initiation of treatment to the date of any reason death while those living subjects will be censored at the last assessment date.

Time frame: Until patient's death (median follow-up 293 days -- range (63-632 days))

ArmMeasureValue (MEDIAN)
Pemetrexed + CarboplatinOverall Survival (OS)9.6 months
Secondary

Overall Survival Rate

Time frame: 1 year

ArmMeasureValue (NUMBER)
Pemetrexed + CarboplatinOverall Survival Rate22.2 percentage of participants
Secondary

Overall Survival Rate

Time frame: 2 years

ArmMeasureValue (NUMBER)
Pemetrexed + CarboplatinOverall Survival Rate0 percentage of participants
Secondary

Time to Disease Progression

-Progressive disease=at least a 20% increase in the sum of the LD of the target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions

Time frame: Until patient progresses (median follow-up 293 days -- range (63-632 days)

ArmMeasureValue (MEDIAN)
Pemetrexed + CarboplatinTime to Disease Progression3.6 months
Secondary

Toxicities

Time frame: 30 days following completion of treatment (maximum number of cycles = 6)

ArmMeasureGroupValue (NUMBER)
Pemetrexed + CarboplatinToxicitiesALT4 participants
Pemetrexed + CarboplatinToxicitiesNeutrophils2 participants
Pemetrexed + CarboplatinToxicitiesPlatelets1 participants
Pemetrexed + CarboplatinToxicitiesWeight loss1 participants
Pemetrexed + CarboplatinToxicitiesAnorexia2 participants
Pemetrexed + CarboplatinToxicitiesLipase1 participants
Pemetrexed + CarboplatinToxicitiesCardiac ischemia/infarction1 participants
Pemetrexed + CarboplatinToxicitiesPancreatitis1 participants
Pemetrexed + CarboplatinToxicitiesTumor pain1 participants
Pemetrexed + CarboplatinToxicitiesChest/thorax pain1 participants
Pemetrexed + CarboplatinToxicitiesHemoglobin8 participants
Pemetrexed + CarboplatinToxicitiesChest pain1 participants
Pemetrexed + CarboplatinToxicitiesDry eye syndrome1 participants
Pemetrexed + CarboplatinToxicitiesAbdominal pain2 participants
Pemetrexed + CarboplatinToxicitiesConstipation3 participants
Pemetrexed + CarboplatinToxicitiesDiarrhea3 participants
Pemetrexed + CarboplatinToxicitiesDysphagia1 participants
Pemetrexed + CarboplatinToxicitiesHiccoughs1 participants
Pemetrexed + CarboplatinToxicitiesMucositis2 participants
Pemetrexed + CarboplatinToxicitiesNausea6 participants
Pemetrexed + CarboplatinToxicitiesOral cavity pain1 participants
Pemetrexed + CarboplatinToxicitiesStomatitis1 participants
Pemetrexed + CarboplatinToxicitiesVomiting4 participants
Pemetrexed + CarboplatinToxicitiesChills2 participants
Pemetrexed + CarboplatinToxicitiesEdema1 participants
Pemetrexed + CarboplatinToxicitiesFatigue5 participants
Pemetrexed + CarboplatinToxicitiesFever1 participants
Pemetrexed + CarboplatinToxicitiesSweating5 participants
Pemetrexed + CarboplatinToxicitiesColitis (c. difficile)1 participants
Pemetrexed + CarboplatinToxicitiesInfection without neutropenia1 participants
Pemetrexed + CarboplatinToxicitiesAST2 participants
Pemetrexed + CarboplatinToxicitiesAlkaline phosphtase2 participants
Pemetrexed + CarboplatinToxicitiesLeukocytes (WBC)3 participants
Pemetrexed + CarboplatinToxicitiesLow CO22 participants
Pemetrexed + CarboplatinToxicitiesLymphopenia6 participants
Pemetrexed + CarboplatinToxicitiesDehydration1 participants
Pemetrexed + CarboplatinToxicitiesHypercalcemia1 participants
Pemetrexed + CarboplatinToxicitiesHyperglycemia3 participants
Pemetrexed + CarboplatinToxicitiesHyperkalemia3 participants
Pemetrexed + CarboplatinToxicitiesHypernatremia3 participants
Pemetrexed + CarboplatinToxicitiesHypoalbuminemia3 participants
Pemetrexed + CarboplatinToxicitiesHypocalcemia1 participants
Pemetrexed + CarboplatinToxicitiesHypoglycemia1 participants
Pemetrexed + CarboplatinToxicitiesHypokalemia1 participants
Pemetrexed + CarboplatinToxicitiesHyponatremia1 participants
Pemetrexed + CarboplatinToxicitiesBack pain1 participants
Pemetrexed + CarboplatinToxicitiesHernia1 participants
Pemetrexed + CarboplatinToxicitiesLimb pain1 participants
Pemetrexed + CarboplatinToxicitiesDizziness3 participants
Pemetrexed + CarboplatinToxicitiesHeadache3 participants
Pemetrexed + CarboplatinToxicitiesNeuropathy - motor1 participants
Pemetrexed + CarboplatinToxicitiesNeuropathy - sensory5 participants
Pemetrexed + CarboplatinToxicitiesInsomnia4 participants
Pemetrexed + CarboplatinToxicitiesMood alteration - anxiety2 participants
Pemetrexed + CarboplatinToxicitiesCreatinine1 participants
Pemetrexed + CarboplatinToxicitiesCreatinine clearance1 participants
Pemetrexed + CarboplatinToxicitiesAllergic rhintis2 participants
Pemetrexed + CarboplatinToxicitiesCough4 participants
Pemetrexed + CarboplatinToxicitiesDyspnea3 participants
Pemetrexed + CarboplatinToxicitiesHemorrhage - nose1 participants
Pemetrexed + CarboplatinToxicitiesAlopecia1 participants
Pemetrexed + CarboplatinToxicitiesDry skin2 participants
Pemetrexed + CarboplatinToxicitiesOther: skin1 participants
Pemetrexed + CarboplatinToxicitiesPuritis1 participants
Pemetrexed + CarboplatinToxicitiesRash1 participants
Pemetrexed + CarboplatinToxicitiesSkin breakdown/decubitous ulcer1 participants
Pemetrexed + CarboplatinToxicitiesHot flash1 participants

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