Weekly Oxaliplatin and Gemcitabine for Recurrent or Metastatic Head and Neck Cancer

This study has been terminated.
(Low accrual)
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Chao Family Comprehensive Cancer Center, University of California, Irvine
ClinicalTrials.gov Identifier:
NCT00256295
First received: November 17, 2005
Last updated: March 25, 2014
Last verified: March 2014
  Purpose

The combination of oxaliplatin and gemcitabine is highly active in a wide variety of tumors including pancreatic, germ cell, breast, biliary, mesothelioma (Mitchell et al, 2002), and lung. In the last study which utilized days 1 and 8 gemcitabine 1000 mg/m2 and days 1 and 8 oxaliplatin 65 mg/m2 in poor prognosis lung cancer patients (PS 1-3) the response rate was 16% with no incidence of febrile neutropenia.

Toxicity is a crucial consideration when designing regimens intended for palliation. Toxicities associated with cisplatin can make it difficult to use in patients with Head and Neck Cancer (HNC), many of whom are elderly and have comorbidities. In addition, many patients with metastatic HNC have previously received cisplatin during neoadjuvant/adjuvant therapy, or as part of their primary chemoradiation treatment. When these patients recur, it is possible their tumors have innate or acquired cisplatin resistance. Oxaliplatin is likely to be better tolerated than cisplatin containing regimens, especially with regards to neurotoxicity. Gemcitabine has shown promising activity as a single agent and in combination chemotherapy in the first line treatment of patients with HNC. A combination chemotherapy regimen using oxaliplatin and gemcitabine administered once every week is logical and worth exploring in patients with metastatic and recurrent head and neck cancer to improve the toxicity profile and patient monitoring while maintaining efficacy of the chemotherapy regimen.


Condition Intervention Phase
Cancer of the Head and Neck
Drug: Gemcitabine
Drug: Oxaliplatin
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Weekly Oxaliplatin and Gemcitabine Combination Chemotherapy for Recurrent or Metastatic Head and Neck Cancer

Resource links provided by NLM:


Further study details as provided by University of California, Irvine:

Primary Outcome Measures:
  • Overall Response Rate (Complete and Partial Response) [ Time Frame: 5 years ] [ Designated as safety issue: No ]

    Complete Response (CR): Complete disappearance of all measurable and non-measurable disease. No new lesions. No disease related symptoms. Normalization of markers and other abnormal lab values. All disease must be assessed using the same techniques as baseline.

    Partial Response (PR): Applies only to patients with at least one measurable lesion. Greater than or equal to 30% decrease under baseline of longest diameters of all target measurable lesions. No unequivocal progression of non-measurable disease. No new lesions. All target measurable lesions must be assessed using the same techniques as baseline.



Secondary Outcome Measures:
  • Frequency and Severity of Toxicities [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Overall Survival and Time to Treatment Failure [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Enrollment: 8
Study Start Date: April 2005
Study Completion Date: October 2011
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Gemcitabine plus Oxaliplatin
Gemcitabine given 1000 mg/m2 IV over 100 minutes Every 21 days. Oxaliplatin given 65 mg/m2 IV over 120 minutes immediately following gemcitabine Every 21 days.
Drug: Gemcitabine
1000 mg/m2 IV over 100 minutes Every 21 days
Other Names:
  • Gemzar
  • NSC-613327
Drug: Oxaliplatin
65 mg/m2 IV over 120 minutes immediately following gemcitabine Every 21 days
Other Name: NSC-266046

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients must have histologically or cytologically confirmed diagnosis of squamous cell carcinoma of the head and neck region. Primary tumor sites include: lip, oral cavity, pharynx (oropharynx, hypopharynx), or larynx (supraglottis, glottis, subglottis). For nasopharynx primary, all squamous histologic subtypes are allowed (WHO type-I keratinizing, WHO type-II non-keratinizing, WHO type-III undifferentiated).
  • Patients must have metastatic or locally recurrent carcinoma of the head and neck. Patients with locoregional disease must be considered incurable by means of locoregional therapy.
  • All sites of disease must be assessed and designated as measurable or non-measurable disease as documented by CT, MRI, X-ray physical exam or nuclear exam. All measurable disease must be assessed within 28 days prior to registration. All non-measurable disease must be assessed within 42 days prior to registration.
  • Patients may have received prior radiotherapy if there has been complete recovery from all radiation-induced toxicities. At least 4 weeks must have been elapsed from the completion of radiation therapy to the time of registration. If lesions within the radiation port are to be used to assess response to therapy, those lesions must have demonstrated clear progression following completion of radiation therapy.
  • Patients must have adequate bone marrow reserve as documented by absolute neutrophil count (ANC) > 1,500 microliters and platelets > 100,000/microliter obtained within 14 days prior to registration.
  • Patients must have adequate hepatic as documented by serum bilirubin < 1.5 x the institutional upper limit of normal. Serum transaminase (SGOT or SGPT) must be < 1.5 x the institutional upper limit of normal serum unless the liver is involved with tumor, in which case serum transaminase (SGOT or SGPT) must be < 5 x the institutional limit of normal. These tests must be obtained within 14 days prior to registration.
  • Patients must have a creatinine < 1.5 x the institutional upper limit of normal or a creatinine clearance of > 30 cc/min calculated using the following formula obtained within 28 days prior to registration.

Calculated Creatinine Clearance = (140-age) X wt (kg) X (0.85 if female) 72 X creatinine (mg/dl)

These tests must have been performed within 28 days prior to registration.

  • All patients must be 18 years of age or older
  • Patients must have a Zubrod performance of 0-2

Exclusion Criteria:

  • Patients must not have more than one prior chemotherapy regimen for recurrent/metastatic disease. Patients with initial locally advanced but non-metastatic disease are allowed to have one prior chemotherapy regimen as part of the primary curative therapy. All chemotherapy must be completed 4 weeks prior to registration. Any number of prior biologic therapies (e.g. chimeric antibodies or kinase inhibitors) is permitted as part of the chemotherapy regimen.
  • Patients must not have a surgical treatment procedure for head and neck cancer within 4 weeks prior to registration. Surgical procedure for biopsy purpose alone is allowed within 28 days prior to registration. Patients must have completely recovered from all surgery prior to registration.
  • Patients must not have prior therapy with oxaliplatin or gemcitabine
  • Patients with any evidence of active or uncontrolled infection, recent myocardial infection, unstable angina, or life threatening arrhythmia are not eligible.
  • Patients with severe psychiatric disorder are not eligible.
  • Patients with known brain metastasis are not eligible. However, brain-imaging studies are not required for eligibility if the patient has no neurological signs or symptoms. If brain-imaging studies are performed, they must be negative for disease.
  • No other prior malignancy is allowed except for adequately treated basal cell or squamous cell carcinoma, in situ cervical cancer, or adequately treated Stage I and II cancer from which the patient is in complete remission, or any other malignancy from which the patient has been disease-free for 5 years.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00256295

Locations
United States, California
Chao Family Comprehensive Cancer Center
Orange, California, United States, 92868
Sponsors and Collaborators
University of California, Irvine
Sanofi
Investigators
Principal Investigator: Ignatius Ou, MD Chao Family Comprehensive Cancer Center
  More Information

No publications provided

Responsible Party: Chao Family Comprehensive Cancer Center, Cancer Center, University of California, Irvine
ClinicalTrials.gov Identifier: NCT00256295     History of Changes
Other Study ID Numbers: UCI 04-08, 2004-3776
Study First Received: November 17, 2005
Results First Received: June 21, 2013
Last Updated: March 25, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Irvine:
Cancer of the Head and Neck

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Gemcitabine
Oxaliplatin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on September 15, 2014