Pemetrexed &Oxaliplatin in Patients w Recurrent NSCLCa After Failure to Platinum Based Adjuvant Chem

NCT00612677 | Terminated Phase 2 Results

• 2 other identifiers: MCC-15010OX-04-006
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is:

• To find out if the chemotherapy treatment using Pemetrexed (Alimta) and Oxaliplatin (Eloxatin) given together will kill the cancer cells in the patient's body and shrink the size of their tumor. This may allow patients to live longer or decrease the frequency and/or severity of the symptoms caused by the cancer. Pemetrexed has been approved by the Food and Drug Administration (FDA) to treat Lung Cancer. Oxaliplatin has been approved by the FDA for the treatment of Colon Cancer. The combination of these two drugs has been used to treat patients with Non-Small Cell Lung Cancer in Italy but not yet in the USA Other purposes of this study are:
• To better detail the toxic effects of this chemotherapy combination.
• To determine whether the level of specific gene and/or gene products (genes are genetic material that allows cells to make proteins such as enzymes) are useful to predict if this chemotherapy combination will work or not.

Conditions

Lung Cancer

Keywords

recurrent; non-small cell

Outcome Measures

Primary Outcomes (1)

• Number of Patients Who Responded to Treatment

  We planned to determine the Overall Response Rate (ORR = CR+PR) of this regimen according to RECIST Criteria.

  Patient will continue study treatment until death, disease progression, unacceptable toxicity, patient refusal, or treatment delay > 3 weeks.

Secondary Outcomes (2)

• Time to Progression (TTP)

  Patient will continue study treatment until death, disease progression, unacceptable toxicity, patient refusal, or treatment delay > 3 weeks.

• Number of Participants Who Experienced Toxicities

  Patient will continue study treatment until death, disease progression, unacceptable toxicity, patient refusal, or treatment delay > 3 weeks.

Study Arms (1)

Premetrexed and Oxaliplatin

EXPERIMENTAL

Patients will be treated with oxaliplatin 120 mg/m\^2 i.v. over 2 hours and pemetrexed 500 mg/m\^2 i.v. over 10 minutes on Day 1 of a 21day cycle. Cycles of treatment will be repeated every 3 weeks. Folic acid and B12 supplementation is obligatory.

Drug: Oxaliplatin; Drug: Pemetrexed

Interventions

Oxaliplatin DRUG

Dose Regimen: 120 mg/m\^2 on Days 1 every 21 days

Also known as: Eloxatin™

Premetrexed and Oxaliplatin

Pemetrexed DRUG

Dose Regimen: 500 mg/m\^2 on Days 1 every 21 days

Also known as: Alimta™

Premetrexed and Oxaliplatin

Eligibility Criteria

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

You may qualify if:

• History of completely resected NSCLC and adjuvant/neoadjuvant chemotherapy with platinum-based regimen
• Histologically/cytologically confirmed recurrence of NSCLC after curative therapy with surgery and adjuvant/neoadjuvant chemotherapy
• Must have measurable disease according to RECIST criteria
• ECOG Performance Score of 0-2 determined within 2 weeks prior to enrollment
• Expected survival \> 12 weeks
• Adequate bone marrow function,as evidenced by:
• Absolute neutrophil count (ANC) \> 1,500/µL
• Platelet count \> 100,000/µL
• Hemoglobin \> 8 g/dL (determined within 2 weeks prior to enrollment)
• Adequate renal function evidenced by:
• serum creatinine \< 1.5 mg/dL OR
• calculated creatinine clearance \>45 mL/min.
• Adequate hepatic function evidenced by:
• Serum total bilirubin \< 1.5 mg/dL OR less than the upper limit of normal (ULN)
• Alkaline phosphatase \< 3X the ULN for the reference lab (\< 5X the ULN for patients with known hepatic or bony metastases)

You may not qualify if:

• Patients amenable to a "curative intent" therapeutic approach (re-resection with or without preoperative or postoperative therapy or chemoradiotherapy without surgery are not eligible for this study).
• An active infection or with fever \> 101.00 F within 3 days of first scheduled day of protocol treatment
• Active CNS metastases. Patients with stable CNS disease, who have undergone radiotherapy (or surgery ± radiotherapy) at least 4 weeks prior to planned first protocol treatment and who have been on stable or decreasing dose of corticosteroids for \>2 weeks are eligible
• Prior malignancy within the past 5 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 most recent evaluation no more than 4 weeks prior to entry.
• Any diagnosis of NSCLC occurring after 5 years of curative therapy (surgery plus adjuvant chemotherapy) for original NSCLC will be considered a second primary rather than a recurrence and will render patient ineligible for this study. An exception will be if both tumors are considered the same after a direct pathologic comparison if both, sponsor and investigator agree.
• Patients that at discretion of the PI have a second primary rather than metastasis are not eligible
• Known hypersensitivity to any of the components of oxaliplatin or pemetrexed.
• Patients receiving concurrent investigational therapy or who have received investigational therapy within 30 days of the first scheduled day of protocol treatment
• Patients who received radiotherapy to more than 33% of their bone marrow or received any radiotherapy within 4 weeks of entry
• Peripheral neuropathy ≥ Grade 2
• Patients pregnant or lactating
• Any other medical condition, including mental illness or substance abuse, deemed likely to interfere with patient's ability to sign informed consent, cooperate and participate in the study, or interfere with interpretation of the results.
• History of allogeneic transplant
• Known history of HIV or Hepatitis B or C infection. Patients with Hepatitis B carrier status only are eligible.

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead
• Sanofi: collaborator

Study Sites (1)

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Location

MeSH Terms

Conditions

Lung Neoplasms; Recurrence

Interventions

Oxaliplatin; Pemetrexed

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

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

Terminated due to slow accrual. Study closed before treatment started.

Results Point of Contact

• Title: Alberto Chiappori, M.D., via Moffitt Cancer Center
• Organization: H. Lee Moffitt Cancer Center and Research Institute

alberto.chiappori@moffitt.org

813-745-3050

Study Officials

• Alberto Chiappori, M.D.

  H. Lee Moffitt Cancer Center and Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

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: January 29, 2008
• First Posted: February 12, 2008
• Study Start: June 1, 2007
• Primary Completion: January 1, 2008
• Study Completion: January 1, 2008
• Last Updated: March 23, 2017
• Results First Posted: April 20, 2011

Record last verified: 2013-12

Locations

US (1)