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S1201: Combination Chemo for Patients W/Advanced or Metastatic Esophageal, Gastric, or Gastroesophageal Junction Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Southwest Oncology Group
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT01498289
First received: December 22, 2011
Last updated: October 15, 2014
Last verified: October 2014

December 22, 2011
October 15, 2014
February 2012
March 2018   (final data collection date for primary outcome measure)
  • Progression-free survival (PFS) between high-ERCC1 and low-ERCC1 patients treated with FOLFOX versus irinotecan hydrochloride plus docetaxel [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
  • PFS between low-ERCC1 and high-ERCC1 patients treated with FOLFOX [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
  • PFS between low-ERCC1 and high-ERCC1 patients treated with irinotecan hydrochloride plus docetaxel [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
  • Progression-free survival (PFS) between high-ERCC1 and low-ERCC1 patients treated with FOLFOX versus irinotecan hydrochloride plus docetaxel [ Designated as safety issue: No ]
  • PFS between low-ERCC1 and high-ERCC1 patients treated with FOLFOX [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01498289 on ClinicalTrials.gov Archive Site
  • Overall survival [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
  • Response rate [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
  • Toxicity [ Time Frame: Up to 3 years ] [ Designated as safety issue: Yes ]
  • Overall survival [ Designated as safety issue: No ]
  • Response rate [ Designated as safety issue: No ]
  • Toxicity [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
S1201: Combination Chemo for Patients W/Advanced or Metastatic Esophageal, Gastric, or Gastroesophageal Junction Cancer
A Randomized Phase II Pilot Study Prospectively Evaluating Treatment for Patients Based on ERCC1(Excision Repair Cross-Complementing 1) for Advanced/Metastatic Esophageal, Gastric or Gastroesophageal Junction (GEJ) Cancer

RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, leucovorin calcium, fluorouracil, irinotecan hydrochloride, and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Combining more than one drug may kill more tumor cells. It is not yet known which regimen of combination chemotherapy is more effective in treating tumor cells.

PURPOSE: This randomized phase II trial studies how well oxaliplatin, leucovorin calcium, and fluorouracil work compared to irinotecan hydrochloride and docetaxel in treating patients with esophageal cancer, gastric cancer, or gastroesophageal junction cancer.

OBJECTIVES:

  • To assess progression-free survival of high-excision repair cross-complementing 1(ERCC1) patients with advanced or metastatic cancer of the esophagus, stomach, or gastroesophageal junction (GEJ) treated with FOLFOX comprising oxaliplatin, leucovorin calcium, and fluorouracil compared to those treated with irinotecan hydrochloride plus docetaxel.
  • To assess progression-free survival of low-ERCC1 patients with advanced or metastatic cancer of the esophagus, stomach, or GEJ treated with FOLFOX compared to those treated with irinotecan hydrochloride plus docetaxel.
  • To assess progression-free survival of low-ERCC1 patients with advanced or metastatic cancer of the esophagus, stomach, or GEJ treated with FOLFOX compared to high-ERCC1 patients treated with FOLFOX.
  • To assess overall survival of and toxicities in each of the two treatment arms in this group of patients.
  • To assess the response probability (confirmed and unconfirmed, complete and partial responses) in the subset of patients with measurable disease in each of the two treatment arms.
  • To explore whether there is evidence of interaction between treatment arm and ERCC1 expression in this group of patients. (Exploratory)
  • To bank tissue and blood for future translational medicine studies; a) To explore the relationship of ERCC-1 and ERCC-2 single nucleotide polymorphism (SNP) genotypes with clinical outcome in these patients; and b) To explore the association between germline variations in these SNPs and ERCC-1 mRNA expression in these patients. (Exploratory)

OUTLINE: This is a multicenter study. Patients are stratified according to ERCC1 expression (high [≥ 1.7] vs low [< 1.7]), and disease site (esophageal vs gastric/gastroesophageal junction). Patients are randomized to 1 of 2 treatment arms.

  • Arm I (FOLFOX): Patients receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV over 46-48 hours on days 1-2. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
  • Arm II: Patients receive irinotecan hydrochloride IV over 90 minutes and docetaxel IV over 30-60 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Blood and tumor tissue samples may be collected for ERCC1 expression analysis and future research studies.

After completion of study treatment, patients are followed up every 3 months for up to 3 years.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Adenocarcinoma of the Gastroesophageal Junction
  • Esophageal Cancer
  • Gastric Cancer
  • Drug: FOLFOX regimen
    Given IV. Fluorouracil, oxaliplatin, & leucovorin calcium.
  • Drug: docetaxel
    30 mg/m^2, IV over 30 minutes on Day 1,8 of each 21 day cycle.
    Other Names:
    • Taxotere
    • RP56976
    • NSC-628503
  • Drug: fluorouracil
    400 mg/m^2, IV bolus on Day 1 of each 14 day cycle; 2400 mg/m^2 IV over 46-48 hours on Days 1-2 of each 14 day cycle.
    Other Names:
    • 5-fluorouracil
    • 5-FU
    • NSC-19893
  • Drug: irinotecan hydrochloride
    65 mg/m^2, IV over 90 minutes on Days 1 & 8 of every 21 day cycle.
    Other Names:
    • CPT-11
    • NSC-616348
  • Drug: leucovorin calcium
    400 mg/m^2, IV over 2 hours on Day 1 of every 14 day cycle.
    Other Name: NSC-3590
  • Drug: oxaliplatin
    85 mg/m^2, IV over 2 hours on Day 1 of every 14 day cycle.
    Other Names:
    • Eloxatin
    • NSC-266046
  • Experimental: Arm I
    FOLFOX regimen: Patients receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV over 46-48 hours on days 1-2. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
    Interventions:
    • Drug: FOLFOX regimen
    • Drug: fluorouracil
    • Drug: leucovorin calcium
    • Drug: oxaliplatin
  • Experimental: Arm II
    Patients receive irinotecan hydrochloride IV over 90 minutes and docetaxel IV over 30-60 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
    Interventions:
    • Drug: docetaxel
    • Drug: irinotecan hydrochloride
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
225
March 2019
March 2018   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Patients must have unresectable advanced or metastatic histologically or cytologically confirmed adenocarcinoma of the esophagus, stomach, or gastroesophageal junction (GEJ)

    • Patients must not have received treatment for metastatic or unresectable disease
    • Patients must not have brain metastases
  • Patients must have measurable and/or non-measurable disease
  • Patients who have had HER-2 expression testing prior to patient consent to this study must be HER-2 negative; if HER-2 expression has not been tested prior to patient consent to this study, a second specimen must be submitted for HER-2 expression; if the specimen is HER-2 positive (or if HER-2 could not be evaluated), the patient will not be randomized
  • Patients must have completed any prior neoadjuvant and adjuvant therapy for resectable disease at least 180 days prior to registration

PATIENT CHARACTERISTICS:

  • Zubrod performance status of 0-1
  • Hemoglobin ≥ 9 g/dL
  • Absolute neutrophil count (ANC) ≥ 1,500/mcL
  • Platelets ≥ 100,000/mcL
  • Total bilirubin ≤ 1.5 mg/dL regardless of whether patients have liver involvement secondary to tumor
  • AST and ALT both ≤ 3 times institutional upper limit of normal (IULN) unless the liver is involved with tumor, in which case both AST and ALT must be ≤ 5 times IULN
  • Serum creatinine < 1.5 mg/dL within 28 days prior to registration AND/OR calculated creatinine clearance > 60 mL/min
  • Patients must not have motor or sensory neuropathy > Grade 1 using CTCAE version 4.0
  • Patients must not be pregnant or nursing; women and men of reproductive potential must have agreed to use an effective contraceptive method
  • No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for five years

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • All palliative radiation therapy alone must be completed at least 14 days prior to registration
  • Patient must have no plans to receive concurrent chemotherapy, hormonal therapy, radiotherapy, immunotherapy, or any other type of therapy for treatment of cancer while on this protocol treatment
Both
18 Years and older
No
Contact: Kimberly Kaberle 2106148808 ext 1022 kkaberle@swog.org
Contact: Dana Sparks, MAT 2106148808 ext 1004 dsparks@swog.org
United States
 
NCT01498289
S1201, S1201, U10CA032102, NCI-2012-00096
Yes
Southwest Oncology Group
Southwest Oncology Group
National Cancer Institute (NCI)
Principal Investigator: Syma Iqbal, MD University of Southern California
Southwest Oncology Group
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP