Gemcitabine and Oxaliplatin as Second-Line Therapy in Treating Patients With Metastatic Colon Cancer

NCT00276861 | Terminated Phase 2 Results DMC

• 3 other identifiers: 20030655SCCC-2003110WIRB-20050993
• Study Type: interventional
• Target: 10
• 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 more than one drug (combination chemotherapy) may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving gemcitabine together with oxaliplatin works as second-line therapy in treating patients with metastatic or recurrent colon cancer.

Conditions

Colorectal Cancer

Keywords

adenocarcinoma of the colon; recurrent colon cancer; stage IV colon cancer

Outcome Measures

Primary Outcomes (1)

• Response Rate as Measured by RECIST Criteria

  Complete Response (CR) or Partial Response (PR) as defined by RECIST v 1.0 criteria.

  4 - 6 months

Secondary Outcomes (1)

• Time to Progression as Measured by the Kaplan Meyer Curve at Completion of Study Treatment

  6 months

Interventions

gemcitabine hydrochloride DRUG

oxaliplatin DRUG

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed adenocarcinoma of the colon * Metastatic or recurrent disease * Redocumentation of tumor histology or cytology prior to protocol therapy is not required if documented tumor was confirmed prior to initial therapy * Measurable disease * Lesion of ≥ 1 cm in longest diameter that can be repetitively assessed by radiographic measurement or any lesion of ≥ 2 cm in longest diameter that can be repetitively assessed by physical examination * Positive bone scans, osteoblastic or osteolytic bone lesions, pleural effusions, and positive bone marrow biopsies are not considered measurable or evaluable lesions * Metastatic disease to the brain allowed if emergent radiotherapy for symptomatic CNS disease is not required * Must have received at least one prior chemotherapy regimen (with or without radiotherapy) * One of the prior regimens must include irinotecan hydrochloride, fluorouracil, and leucovorin calcium or irinotecan hydrochloride and other fluoropyrimidine * Previous therapy with C-225 and/or bevacizumab is allowed * . PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * Granulocyte count ≥1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Creatinine ≤ 2.0 mg/dL * Bilirubin \< 1.5 mg/dL * SGOT ≤ 2 times upper limit of normal (ULN) * Alkaline phosphatase \< 2.5 times ULN * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No serious medical or psychiatric illness that would render chemotherapy unsafe * No concurrent clinically evident malignancy except inactive nonmelanoma skin cancer, low-grade low-stage bladder carcinoma followed off therapy, or lobular neoplasia of the breast * No clinical AIDS or known positive HIV serology PRIOR CONCURRENT THERAPY: * See Disease Characteristics * Recovered from prior therapy * No investigational agent for at least 30 days prior to study entry * No chemotherapy within the past 3 weeks * No radiotherapy for palliation within the past 2 weeks prior to study entry * No prior oxaliplatin or gemcitabine hydrochloride * No concurrent participation in another clinical trial * No other concurrent anticancer therapy including chemotherapy, radiotherapy, hormonal therapy, or immunotherapy * No other concurrent investigational drugs

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

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami Sylvester Comprehensive Cancer Center

Miami, Florida, 33136, United States

Location

Related Publications (1)

• Lopes G, Quesada J, Ahn E, Flores A, Ribeiro A, Rocha-Lima CM. Oxaliplatin and fixed-rate infusional gemcitabine in the second-line treatment of patients with metastatic colon cancer: final results of a Phase II trial prematurely closed as a result of poor accrual. Clin Colorectal Cancer. 2007 Sep;6(9):641-5. doi: 10.3816/CCC.2007.n.032.

  PMID: 17945036 RESULT

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Neoplasms

Interventions

Gemcitabine; Oxaliplatin

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Coordination Complexes; Organic Chemicals

Limitations and Caveats

Protocol closed prematurely due to low accrual. Only 10 of 27 anticipated patients were enrolled.

Results Point of Contact

• Title: Gilberto Lopes MD
• Organization: Dept. of Oncology Johns Hopkins Singapore Intl Medical Center

glopes@imc.jhmi.edu

656-880-2240

Study Officials

• Caio Max S. Rocha Lima, MD

  University of Miami Sylvester Comprehensive Cancer Center

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2006
• First Posted: January 13, 2006
• Study Start: September 1, 2005
• Primary Completion: September 1, 2006
• Study Completion: May 1, 2008
• Last Updated: February 8, 2017
• Results First Posted: February 26, 2013

Record last verified: 2016-12

Locations

US (1)