Gemcitabine and Oxaliplatin in Treating Patients With Pancreatic Cancer That Can Be Removed By Surgery

NCT00536874 | Completed Phase 2 Results

• 2 other identifiers: 07-113MSKCC-07113
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as gemcitabine and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving chemotherapy after surgery may kill any tumor cells that remain after surgery. PURPOSE: This phase II trial is studying how well giving gemcitabine together with oxaliplatin works in treating patients with pancreatic cancer that can be removed by surgery.

Conditions

Pancreatic Cancer

Keywords

adenocarcinoma of the pancreas; stage IA pancreatic cancer; stage IB pancreatic cancer; stage IIA pancreatic cancer; stage IIB pancreatic cancer; stage III pancreatic cancer

Outcome Measures

Primary Outcomes (1)

• Overall Survival at 18 Months

  Percentage of participants that were alive or survived at 18 months after randomization

  18 months

Secondary Outcomes (6)

• Overall Survival (Follow-Up Time)

  From Baseline until 2 Years and Follow-Up, up to 120 months

• Specific Tumor Marker Response (CEA) to Neoadjuvant Therapy

  Baseline and 2 years

• RECIST Radiologic Response to Neoadjuvant Therapy

  2 years

• Specific Tumor Marker Response (Ca 19-9) to Neoadjuvant Therapy

  Baseline and 2 years

• Specific Tumor Marker Response (CEA) to Neoadjuvant Therapy

  Baseline and 2 years

Study Arms (1)

Gemcitabine And Oxaliplatin

EXPERIMENTAL

A Phase II Study of Neoadjuvant Gemcitabine And Oxaliplatin In Patients With Potentially Resectable Previously Untreated Pancreatic Adenocarcinoma

Drug: gemcitabine hydrochloride; Drug: oxaliplatin; Genetic: protein expression analysis; Genetic: proteomic profiling; Other: diagnostic laboratory biomarker analysis; Procedure: adjuvant therapy; Procedure: neoadjuvant therapy; Procedure: therapeutic conventional surgery

Interventions

gemcitabine hydrochloride DRUG

1,000 mg/m2 IV over 100 minutes on day 1 every 14 days for 4 cycles

Gemcitabine And Oxaliplatin

oxaliplatin DRUG

80 mg/m2 IV over 2 hours on day 1 every 14 days for 4 cycles.

Gemcitabine And Oxaliplatin

protein expression analysis GENETIC

Gemcitabine And Oxaliplatin

proteomic profiling GENETIC

Gemcitabine And Oxaliplatin

diagnostic laboratory biomarker analysis OTHER

Gemcitabine And Oxaliplatin

adjuvant therapy PROCEDURE

Gemcitabine And Oxaliplatin

neoadjuvant therapy PROCEDURE

Gemcitabine And Oxaliplatin

therapeutic conventional surgery PROCEDURE

Gemcitabine And Oxaliplatin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed pancreatic adenocarcinoma * No histology other than adenocarcinoma (e.g., neuroendocrine cancer or acinar cancer) * Patients with adenosquamous variants are eligible * Radiographically resectable pancreatic cancer, as determined by a surgical oncologist * No metastatic or locally unresectable pancreatic adenocarcinoma * No evidence of distant metastases by CT scan * Negative or pending laparoscopy for distant metastases PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * Absolute neutrophil count ≥ 1,500/mm³ * Platelet count ≥ 100,000/mm³ * Bilirubin ≤ 4.0 mg/dL (if \> 3.0, stented and known to be declining) * Serum creatinine ≤ 1.6 mg/dL * INR \< 1.5 (therapeutic INR is allowed for patients receiving therapeutic anticoagulation) * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 3 months after completion of study therapy * No active infection, except for resolving cholangitis, that would preclude study enrollment * Neoadjuvant therapy may only be initiated when acute cholangitis has resolved * No other malignancy within the past 3 years except for curatively treated basal cell carcinoma of the skin, cervical intraepithelial neoplasia, or localized prostate cancer with a PSA of \< 5.0 ng/mL within ≥ 4 weeks of study entry (other circumstances with a recent concurrent or active malignancy will be adjudicated on a case-by-case basis by the principle investigator \[PI\] or co-PI) * No known hypersensitivity to any of the components of oxaliplatin or gemcitabine * No hypersensitivity to CT scan IV contrast dye not suitable for premedication * No peripheral neuropathy ≥ grade 2 * No known HIV or hepatitis B or C infection (active, previously treated, or both) * No other medical condition, including mental illness or substance abuse that, deemed by the investigator, would preclude study participation PRIOR CONCURRENT THERAPY: * More than 4 weeks since prior radiotherapy * No prior radiotherapy to \> 25% of bone marrow * More than 30 days since prior and no other concurrent investigational therapy * No other prior therapy for pancreatic cancer * No other concurrent chemotherapy, immunotherapy, or radiotherapy during neoadjuvant therapy * Concurrent low molecular weight heparin or warfarin, where medically indicated, allowed

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065-0009, United States

Location

Related Publications (1)

• O'Reilly EM, Perelshteyn A, Jarnagin WR, Schattner M, Gerdes H, Capanu M, Tang LH, LaValle J, Winston C, DeMatteo RP, D'Angelica M, Kurtz RC, Abou-Alfa GK, Klimstra DS, Lowery MA, Brennan MF, Coit DG, Reidy DL, Kingham TP, Allen PJ. A single-arm, nonrandomized phase II trial of neoadjuvant gemcitabine and oxaliplatin in patients with resectable pancreas adenocarcinoma. Ann Surg. 2014 Jul;260(1):142-8. doi: 10.1097/SLA.0000000000000251.

  PMID: 24901360 DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Gemcitabine; Oxaliplatin; Chemotherapy, Adjuvant; Neoadjuvant Therapy

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Coordination Complexes; Organic Chemicals; Combined Modality Therapy; Therapeutics; Drug Therapy

Results Point of Contact

• Title: Dr. Eileen O'Reilly
• Organization: Memorial Sloan-Kettering Cancer Center

oreillye@mskcc.org

646-888-4182

Study Officials

• Eileen O'Reilly, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

• Peter J. Allen, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2007
• First Posted: September 28, 2007
• Study Start: October 1, 2007
• Primary Completion: September 1, 2012
• Study Completion: February 1, 2017
• Last Updated: March 16, 2017
• Results First Posted: December 17, 2015

Record last verified: 2017-02

Locations

US (1)