Pemetrexed and Oxaliplatin in Treating Patients With Locally Advanced Head and Neck Cancer

NCT00503997 | Completed Phase 2 Results DMC

• 3 other identifiers: VICC HN 0582VU-VICC-HN-0582VU-VICC-IRB-060100
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 7

Brief Summary

RATIONALE: Pemetrexed may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving pemetrexed together with oxaliplatin may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving pemetrexed together with oxaliplatin works in treating patients with locally advanced head and neck cancer.

Conditions

Head and Neck Cancer

Keywords

stage III squamous cell carcinoma of the hypopharynx; stage III squamous cell carcinoma of the larynx; stage III squamous cell carcinoma of the lip and oral cavity; stage III squamous cell carcinoma of the oropharynx; stage III squamous cell carcinoma of the paranasal sinus and nasal cavity; stage IV squamous cell carcinoma of the hypopharynx; stage IV squamous cell carcinoma of the larynx; stage IV squamous cell carcinoma of the lip and oral cavity; stage IV squamous cell carcinoma of the oropharynx; stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity; untreated metastatic squamous neck cancer with occult primary

Outcome Measures

Primary Outcomes (1)

• Patient Response to Treatment Measured by RECIST Criteria

  RECIST response categories: Progressive disease (PD): \>=20% increase in sum of longest diameter (LD) of target lesion(s), taking as reference smallest sum LD recorded since treatment started. Complete response (CR): disappearance of all target lesions. Partial response (PR): \>=30% decrease in sum of LD of target lesion(s), taking as reference baseline sum LD. Stable disease (SD): neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD.

  at 8 weeks

Study Arms (1)

drug therapy

EXPERIMENTAL

Drug: oxaliplatin; Drug: pemetrexed disodium

Interventions

oxaliplatin DRUG

Group I: Patients receive pemetrexed disodium IV and oxaliplatin IV over 2 hours on day 1. Treatment repeats every 14 days for up to 4 courses. If patient progresses before receiving 4 courses of treatment, treatment will be discontinued and patient will proceed to surgery. Group II: Patients receive treatment as in group I. If patient progresses before receiving 4 courses of treatment, treatment will be discontinued and patient will proceed to concurrent chemoradiotherapy.

Also known as: Eloxatin

drug therapy

pemetrexed disodium DRUG

Group I: Patients receive pemetrexed disodium IV and oxaliplatin IV over 2 hours on day 1. Treatment repeats every 14 days for up to 4 courses. If patient progresses before receiving 4 courses of treatment, treatment will be discontinued and patient will proceed to surgery. Group II: Patients receive treatment as in group I. If patient progresses before receiving 4 courses of treatment, treatment will be discontinued and patient will proceed to concurrent chemoradiotherapy.

Also known as: Alimta

drug therapy

Eligibility Criteria

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

You may qualify if:

• Patients must meet all of the following criteria in order to be eligible for entry into the trial:
• Histologically or cytologically confirmed stage III - IVB HNSCC (includes unknown primary and ParaNasal Sinus cancers)but excludes nasopharyngeal, salivary gland or skin primaries (No TNM staging required)
• Patients must have a measurable disease defined by RECIST criteria
• Age \> 18 years
• ECOG Performance Score of 0, 1 or 2
• Adequate bone marrow as evidenced by:
• Absolute neutrophil count \> 1,500/μL
• Platelet count \> 100,000/μL
• Adequate renal function as evidenced by serum creatinine \< 1.5 mg/dL and CrCl \> 45 mL/min as determined by calculated creatinine clearance using the Cockroft-Gault formula:
• CrCl = (140-age) x (weight in kg)/72 x serum creatinine
• Multiply by 0.85 (85%) for females
• Adequate hepatic function as evidenced by:
• Serum total bilirubin \< 1.5 mg/dL
• Alkaline phosphatase \< 3X the ULN for the reference lab
• SGOT/SGPT \< 3X the ULN for the reference lab

You may not qualify if:

• A patient may not be enrolled in the trial if any of the following criteria are met:
• Patients with an active infection or with a fever \> 101.30 F within 3 days of the first scheduled day of protocol treatment
• History of prior malignancy within the past 3 years except for curatively treated basal cell carcinoma of the skin, cervical intra-epithelial neoplasia, or localized prostate cancer with a current PSA of \< 1.0 mg/dL on 2 successive evaluations, at least 3 months apart, with the most recent evaluation no more than 4 weeks prior to entry
• Patients with known hypersensitivity to any of the components of Oxaliplatin and Pemetrexed
• Patients who received any chemotherapy, radiation therapy or surgical resection other than diagnostic biopsies for HNSCC prior to the first scheduled day of protocol treatment
• Patients who are receiving concurrent investigational therapy or who have received investigational therapy within 30 days of the first scheduled day of protocol treatment(investigational therapy is defined as treatment for which there is currently no regulatory authority approved indication)
• Peripheral neuropathy ≥ Grade 2
• Patients who are pregnant or lactating
• Any other medical condition, including mental illness or substance abuse, deemed by the Investigator to be likely to interfere with a patient's ability to sign informed consent,cooperate and participate in the study, or interferes with the interpretation of the results.
• History of allogeneic transplant
• Known HIV (active, previously treated or both)
• Presence of clinically detectable (by physical exam) third-space fluid collections, for example, ascites or pleural effusions that cannot be controlled by drainage or other procedures prior to study entry.

Sponsors & Collaborators

• Vanderbilt-Ingram Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (7)

Mitchell Memorial Cancer Center at Owensboro Medical Health System

Owensboro, Kentucky, 42303, United States

Location

Purchase Cancer Group - Paducah

Paducah, Kentucky, 42002, United States

Location

West Tennessee Cancer Center at Jackson-Madison County General Hospital

Jackson, Tennessee, 38301, United States

Location

Vanderbilt-Ingram Cancer Center - Cool Springs

Nashville, Tennessee, 37064, United States

Location

Vanderbilt-Ingram Cancer Center at Franklin

Nashville, Tennessee, 37064, United States

Location

MBCCOP - Meharry Medical College - Nashville

Nashville, Tennessee, 37208, United States

Location

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232-6838, United States

Location

Related Publications (2)

• Chung CH, Lee JW, Slebos RJ, Howard JD, Perez J, Kang H, Fertig EJ, Considine M, Gilbert J, Murphy BA, Nallur S, Paranjape T, Jordan RC, Garcia J, Burtness B, Forastiere AA, Weidhaas JB. A 3'-UTR KRAS-variant is associated with cisplatin resistance in patients with recurrent and/or metastatic head and neck squamous cell carcinoma. Ann Oncol. 2014 Nov;25(11):2230-2236. doi: 10.1093/annonc/mdu367. Epub 2014 Jul 31.

  PMID: 25081901 DERIVED

• Psyrri A, Rampias T, Vermorken JB. The current and future impact of human papillomavirus on treatment of squamous cell carcinoma of the head and neck. Ann Oncol. 2014 Nov;25(11):2101-2115. doi: 10.1093/annonc/mdu265. Epub 2014 Jul 23.

  PMID: 25057165 DERIVED

MeSH Terms

Conditions

Head and Neck Neoplasms; Squamous Cell Carcinoma of Head and Neck

Interventions

Oxaliplatin; Pemetrexed

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic

Limitations and Caveats

The two cohorts of pemetrexed and oxaliplatin patients represented similar populations, thus the response data were combined.

Results Point of Contact

• Title: Jill Gilbert, M.D.
• Organization: Vanderbilt-Ingram Cancer Center

jill.gilbert@vanderbilt.edu

615-343-4677

Study Officials

• Jill Gilbert, MD

  Vanderbilt-Ingram Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine; Director, Hematology/Oncology Fellowship Program; Section Chief, Solid Tumor Oncology; Medical Oncologist

Study Record Dates

• First Submitted: July 17, 2007
• First Posted: July 19, 2007
• Study Start: December 1, 2006
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2010
• Last Updated: May 10, 2012
• Results First Posted: March 12, 2012

Record last verified: 2012-05

Locations

US (7)