Gemox as First and Second Line Therapy in Unknown Primary Cancer

NCT00353145 | Completed Phase 2

• 1 other identifier: 2003-0946
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

Primary objectives:

1. 1.To determine the overall tumor response rate with oxaliplatin in combination with gemcitabine (GEMOX) as first line and second line therapy in unknown primary cancer (UPC).
2. 2.To determine the tolerability (toxicity) of this regimen in this patient population.
3. 3.To determine the median overall survival (OS) and time to progression (TTP) for patients treated with this combination.
4. 4.To determine the impact of this combination on quality of life (QOL) in this patient population.

Conditions

Unknown Primary Neoplasms

Keywords

Unknown Primary Neoplasms; UPC; Unknown Primary Cancer; Questionnaire; Gemcitabine; Gemcitabine Hydrochloride; Gemzar; Oxaliplatin; Eloxatin; Gemox

Outcome Measures

Primary Outcomes (1)

• Participants' Response

  Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least 30% decrease in sum of longest diameter (LD) of target lesions, reference baseline sum LD; Progressive Disease (PD): At least 20% increase in sum of LD of target lesions, reference smallest sum LD recorded since treatment started or appearance of 1 or more new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor increase to qualify for PD, reference smallest sum LD since treatment started.

  Response to treatment measured using Response Evaluation Criteria in Solid Tumors (RECIST) criteria with radiological evaluation at 6 weeks and reevaluated every 6 weeks.

Study Arms (1)

Gemcitabine + Oxaliplatin

EXPERIMENTAL

Gemcitabine 1000 mg/m\^2, infused at 10 mg/m\^2/min on Day 1 and Oxaliplatin 100 mg/m\^2 by vein infused on Day 2 over two hours. Repeated every 14 days (one cycle).

Drug: Gemcitabine (Gemox); Drug: Oxaliplatin; Behavioral: Questionnaire

Interventions

Gemcitabine (Gemox) DRUG

1000 mg/m\^2, infused at 10 mg/m\^2/min on Day 1 repeated every 14 days (one cycle).

Also known as: Gemcitabine Hydrochloride, Gemzar

Gemcitabine + Oxaliplatin

Oxaliplatin DRUG

100 mg/m\^2 by vein infused on Day 2 over two hours, repeated every 14 days (one cycle).

Also known as: Eloxatin

Gemcitabine + Oxaliplatin

Questionnaire BEHAVIORAL

Quality of Life Surveys

Gemcitabine + Oxaliplatin

Eligibility Criteria

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

You may qualify if:

• Age \>/= 18 years old.
• Signed informed consent/authorization is obtained prior to conducting any study-specific screening procedures.
• Patients should fulfill the criteria for UPC: no primary detected after a complete evaluation which is defined as complete history and physical, detailed laboratory examination, directed radiologic studies, symptom or sign directed invasive studies, directed immunohistochemistry studies and serum tumor markers.
• Previously untreated or has received no more than one prior chemotherapy regimen for unknown primary cancer. If the patients are previously treated, they may not have had previous exposure to gemcitabine or oxaliplatin. Prior exposure to cisplatin or carboplatin is allowed for this study.
• ECOG performance status must be 0-2 (Appendix A).
• Adequate hepatic, renal and bone marrow function: Leukocytes \>= 3,000/uL; Absolute neutrophil count \>= 1,500/uL; Platelets \>= 100,000/uL; Total bilirubin \<= 1.5 \* institutional upper limits of normal (ULN); AST (SGOT)/ALT (SGPT) \<= 2.5 \* institutional ULN; Creatinine \<= 1.5 mg/dL.
• Women of childbearing potential are not excluded from this study; however all participants (men and women) with reproductive potential must practice an effective method of contraception while on this study in order to minimize risks to fetuses.
• Patients may have received prior radiation treatment but the last fraction of radiation treatment must have been completed at least 4 weeks prior to entry on this study.
• Patients must have at least one measurable lesion as per the RECIST Criteria that can be accurately measured in at least one dimension, with minimum lesion size equal to or more than twice the thickness of the imaging study used. If radiation was previously received, measurable disease must occur outside the previous radiation field, unless disease progression has been documented.
• Both men and women and members of all ethnic groups are eligible for this trial.

You may not qualify if:

• In previously treated patients; patients should not have received gemcitabine or oxaliplatin as one of the agents.
• Uncontrolled intercurrent illness including, but not limited to, active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmias not well controlled with medication, myocardial infarction within the previous 6 months, or psychiatric illness/social situations that would limit compliance with study requirements.
• Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurological dysfunction that would confound the evaluation of neurological and other adverse events. A CT scan of the brain is not needed for eligibility and will be done only if the patient presents with symptoms suggestive of brain metastases.
• Patients who have had chemotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 28 days earlier.
• Patients may not be receiving any other investigational agents, or have participated in any investigational drug study within 28 days preceding start of study treatment.
• The teratogenic potential of this combination is currently unknown. Women who are pregnant or lactating are excluded.
• History of any other malignancy in the last 5 years, except patients with a prior history of in situ cancer or basal or squamous cell skin cancer are eligible.
• Peripheral neuropathy \> grade 1.
• Female patients with adenocarcinoma with axillary only nodes will be excluded from the study.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Sanofi-Synthelabo: collaborator

Study Sites (1)

U.T. M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Carlson H, Lenzi R, Raber MN, Varadhachary GR. A phase II study to evaluate the efficacy and toxicity of oxaliplatin in combination with gemcitabine in carcinoma of unknown primary. Int J Clin Oncol. 2013 Apr;18(2):226-31. doi: 10.1007/s10147-011-0366-4. Epub 2012 Jan 5.

  PMID: 22218909 DERIVED

Related Links

• UT MD Anderson Cancer Center website

MeSH Terms

Conditions

Neoplasms, Unknown Primary

Interventions

Gemcitabine; Oxaliplatin; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neoplasm Metastasis; Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Coordination Complexes; Organic Chemicals; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Gauri R. Varadhachary, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: July 13, 2006
• First Posted: July 17, 2006
• Study Start: February 1, 2004
• Primary Completion: March 1, 2007
• Study Completion: January 1, 2010
• Last Updated: August 2, 2012

Record last verified: 2012-08

Locations

US (1)