A Phase 2 interventional study of carboplatin and Pemetrexed in Esophageal Cancer, sponsored by Alliance for Clinical Trials in Oncology. Terminated at 90 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-07-06.
Sponsored by Alliance for Clinical Trials in Oncology · Phase 2, Interventional, and Treatment
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as pemetrexed disodium and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Pemetrexed disodium may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving radiation therapy together with pemetrexed disodium and carboplatin before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
PURPOSE: This phase II trial is studying how well giving radiation therapy together with pemetrexed disodium and carboplatin works in treating patients with locally advanced esophageal cancer that can be removed by surgery.
OBJECTIVES:
Primary
* Determine the pathologic complete response rate of radiotherapy, pemetrexed disodium, and carboplatin when administered prior to esophagectomy in patients with locally advanced esophageal cancer.
Secondary
Quality of life is assessed at baseline, immediately prior to day 22 of chemotherapy, and within 2 weeks prior to surgery.
After completion of study treatment, patients are followed periodically for approximately 4 years.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.
1,631 studies on the registry are indexed under Esophageal Neoplasms; 469 are open to participants now.
This study's enrollment of 27 is below the median of 60 across 1,198 interventional studies indexed under Esophageal Neoplasms.
Browse Esophageal Neoplasms studies →Alliance for Clinical Trials in Oncology is the lead sponsor of 509 studies on the registry; 28 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed squamous cell carcinoma or adenocarcinoma of the esophagus or gastroesophageal (GE) junction
No palpable or biopsy-proven involvement of supraclavicular nodes or radiographically involved supraclavicular nodes (> 1.5 cm in greatest dimension) for lesions in mid-thoracic, distal thoracic, or GE junction
+ Supraclavicular node involvement allowed provided there are upper thoracic esophagus primary lesions
Tumor must be considered surgically resectable
- Patients with T4, N0 tumors that are potentially resectable are eligible
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Pemetrexed+Carboplatin+Radiation
Drug: carboplatin · Drug: Pemetrexed · Procedure: conventional surgery · Procedure: neoadjuvant therapy · Radiation: radiation therapy
carboplatin is to be given on days 1 and 22 of the 5 ½ weeks of radiation treatment.
Pemetrexed is to be given on days 1 and 22 of the 5 ½ weeks of radiation treatment.
Radiation therapy begins day 1 and continues for 5 ½ weeks (45 Gy in 22-25 fractions of 1.8 Gy to extended field; 50.4 Gy in 28 fractions within boost field).
Pathologic Complete Response Rate
The proportion of pathologic complete responses will be estimated by the number of pathologic complete responses divided by the total number of evaluable patients. Ninety-five percent confidence intervals for the true pathologic complete response rate will be calculated. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for Measurable disease is defined as at least one lesion whose longest diameter can be accurately measured as ≥2.0 cm with conventional techniques or as ≥1.0 cm with spiral CT. Lesions on chest x-ray are acceptable as measurable lesions when they are clearly defined and surrounded by aerated lung. However, CT is preferable.
Time frame: Baseline to time of surgery (around 10 - 18 weeks post-baseline)
Overall Survival
Time from registration to death due to any cause.
Time frame: From baseline to 4 years
This trial closed early because, during an interim analysis, the primary endpoint fell short. However, 26 eligible patients were accrued. Due to early closure not all the endpoints were analyzed.
| Milestone | Pemetrexed/Carboplatin |
|---|---|
| Started | 27 |
| Completed | 26 |
| Not completed | 1 |
| Withdrew: Ineligible | 1 |
The proportion of pathologic complete responses will be estimated by the number of pathologic complete responses divided by the total number of evaluable patients. Ninety-five percent confidence intervals for the true pathologic complete response rate will be calculated. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for Measurable disease is defined as at least one lesion whose longest diameter can be accurately measured as ≥2.0 cm with conventional techniques or as ≥1.0 cm with spiral CT. Lesions on chest x-ray are acceptable as measurable lesions when they are clearly defined and surrounded by aerated lung. However, CT is preferable.
| percentage of participants | Pemetrexed/Carboplatin |
|---|---|
| Pathologic Complete Response Rate | 23 (9 to 44) |
Time from registration to death due to any cause.
| months | Pemetrexed/Carboplatin |
|---|---|
| Overall Survival | 17.8 (12.2 to 30.7) |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pemetrexed/Carboplatin | — | 6/27 (22.2%) | 27/27 (100%) |
| Event | Pemetrexed/Carboplatin |
|---|---|
| Hemoglobin decreasedBlood and lymphatic system disorders | 1/27 |
| Atrial fibrillationCardiac disorders | 1/27 |
| DysphagiaGastrointestinal disorders | 1/27 |
| Esophageal fistulaGastrointestinal disorders | 1/27 |
| NauseaGastrointestinal disorders | 1/27 |
| Small intestinal obstructionGastrointestinal disorders | 1/27 |
| VomitingGastrointestinal disorders | 1/27 |
| SepsisInfections and infestations | 1/27 |
| Leukocyte count decreasedInvestigations | 1/27 |
| Neutrophil count decreasedInvestigations | 1/27 |
| Event | Pemetrexed/Carboplatin |
|---|---|
| Hemoglobin decreasedBlood and lymphatic system disorders | 25/27 |
| Leukocyte count decreasedInvestigations | 24/27 |
| Neutrophil count decreasedInvestigations | 23/27 |
| Platelet count decreasedInvestigations | 23/27 |
| DysphagiaGastrointestinal disorders | 20/27 |
| NauseaGastrointestinal disorders | 19/27 |
| EsophagitisGastrointestinal disorders | 16/27 |
| DiarrheaGastrointestinal disorders | 11/27 |
| Esophageal painGastrointestinal disorders | 11/27 |
| Rash desquamatingSkin and subcutaneous tissue disorders | 10/27 |
| Age, Continuous(years) | Pemetrexed/Carboplatin |
|---|---|
| Median | 66 (42 to 84) |
| Sex: Female, Male(Participants) | Pemetrexed/Carboplatin |
|---|---|
| Female | 7 |
| Male | 20 |
| Region of Enrollment(participants) | Pemetrexed/Carboplatin |
|---|---|
| United States | 27 |
The record gives a start of Apr 2006, a primary completion of Jan 2008 and a completion of Mar 2015. It does not say whether these dates are actual or estimated.
Results were first posted in Mar 2015, 7 years 2 months after primary completion.
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This study is terminated, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Carboplatin · Pemetrexed
Alliance for Clinical Trials in Oncology →