Clinical trial · Interventional

Irinotecan, Cisplatin, and Radiation Therapy With or Without Celecoxib in Treating Patients With Stage II, Stage III, or Stage IV Esophageal Cancer

A Pilot Study of the Biologic Efficacy and Safety of the Addition of Celecoxib to a Program of Induction Chemotherapy and Neo-Adjuvant Chemo-Radiotherapy for the Treatment of Esophageal Cancer

NCT00520091CI-TRIAL-00006952completedPhase 2ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

RATIONALE: Drugs used in chemotherapy, such as irinotecan and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Celecoxib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving chemotherapy and radiation therapy together with celecoxib may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving irinotecan and cisplatin together with radiation therapy with or without celecoxib works in treating patients with stage II, stage III, or stage IV esophageal 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
Esophageal Cancer	Malignant Esophageal Neoplasm	CURATED_EXACT	0.92

Interventions

Interventions (5)

Intervention	Type	Mapped drug	Match
Celecoxib	Drug	Celecoxib	ALIAS
Cisplatin	Drug	Cisplatin	ALIAS
CPT- 11	Drug	—	UNRESOLVED
Radiation	Radiation	—	UNRESOLVED
Surgery	Procedure	—	UNRESOLVED

Design

Arms and outcomes

Arms (2)

type
ACTIVE_COMPARATOR
label
Cohort 1
description
Induction chemotherapy and chemoradiation without celecoxib
interventionNames
1. Drug: CPT- 11
2. Drug: Cisplatin
3. Radiation: Radiation
4. Procedure: Surgery
type
EXPERIMENTAL
label
Cohort 2
description
Induction chemotherapy and chemoradiation with celecoxib
interventionNames
1. Drug: CPT- 11
2. Drug: Cisplatin
3. Drug: Celecoxib
4. Radiation: Radiation
5. Procedure: Surgery

Primary outcomes (2)

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

DISEASE CHARACTERISTICS:

* Biopsy proven squamous cell carcinoma or adenocarcinoma of the esophagus

  * Lesions including the gastroesophageal junction allowed provided the tumor involves less than 2 cm of gastric cardia
* Meets 1 of the following criteria:

  * Clinical stage II, III, or IV disease AND planning to receive chemoradiotherapy either for preoperative or palliative indications (group 1)

    * Suitable candidate for bimodality (palliative intent) or trimodality (curative intent) therapy
  * Clinical stage II or III disease AND candidate to receive chemoradiotherapy for preoperative indication followed by planned esophagectomy or esophagogastrectomy (group 2)

    * Suitable candidate for trimodality (curative intent) therapy
* No tracheoesophageal fistula on bronchoscopy

PATIENT CHARACTERISTICS:

* ECOG performance status 0-2
* Life expectancy \> 3 months (group 1)
* Not pregnant
* Adequate nutrition
* WBC ≥ 4,000/μL
* ANC ≥ 1,500/μL
* Platelet count ≥ 100,000/μL
* Serum creatinine ≤ 1.5 mg/dL
* Bilirubin ≤ 1.5 mg/dL
* No other prior or concurrent malignancy other than curatively treated carcinoma in situ of the cervix; localized prostate cancer that was previously treated with local therapy more than 2 years ago with a PSA of less than 4 ng/mL; basal cell carcinoma of the skin; or superficial transitional cell carcinoma of the bladder

  * Patients who have had a prior malignancy are eligible if they have been free of disease for ≥ 5 years
* No serious medical or psychiatric illnesses that would preclude giving informed consent or otherwise limit survival to less than 2 years
* No history of known NSAID-induced gastrointestinal bleeding
* No current peptic ulcer disease
* No active coronary artery disease
* No myocardial infarction or cerebrovascular accident within the past 3 months
* No history of refractory congestive heart failure or cardiomyopathy

PRIOR CONCURRENT THERAPY:

* More than 1 week since prior major surgery (group 1)
* More than 2 weeks since prior major surgery (group 2)
* No prior chemotherapy or radiotherapy
* More than 30 days since prior cyclooxygenase-2 inhibitors (selective or non-selective), including, but not limited to, any of the following:

  * Acetylsalicylic acid (aspirin)
  * Piroxicam
  * Diclofenac
  * Meloxicam
  * Indomethacin
  * Fenoprofen
  * Sulindac
  * Flurbiprofen
  * Tolmetin
  * Ibuprofen
  * Celecoxib
  * Ketoprofen
  * Rofecoxib
  * Ketoprofen ER
  * Valdecoxib
  * Naproxen
  * Meclofenamate
  * Oxaprozin
  * Mefenamic acid
  * Etodolac
  * Nabumetone
  * Ketorolac
* No concurrent seizure medications
* No concurrent amifostine or other such agents

References

Publications (0)

Data not yet available

No reference posted for this study.