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Phase II Combination of Pemetrexed and Oxaliplatin in Patients With Recurrent Non-Small Cell Lung Cancer After Failure to Platinum Based Adjuvant Chemotherapy

Phase 2
18 Years
Not Enrolling
Lung Cancer

Thank you

Trial Information

Phase II Combination of Pemetrexed and Oxaliplatin in Patients With Recurrent Non-Small Cell Lung Cancer After Failure to Platinum Based Adjuvant Chemotherapy

Treatment Plan:

This is a non-randomized, two stage design, open-label Phase II trial in newly diagnosed
patients with advanced or metastatic NSCLC who have previously received and failed adjuvant
platinum-based chemotherapy for early stage, resected NSCLC.

Correlative Studies; Molecular correlative studies (genomic and proteomic) are included in
this protocol. Prior to chemotherapy, all patients will undergo a biopsy of the safest
and/or most accessible site of tumor in order to obtain tissue for mRNA measurements.
Additionally, patients will undergo blood sampling prior to the start of chemotherapy and
after 2 and 4 cycles of therapy in order to obtain plasma for the mass spectrometry

Patients, whose second and/or third specimen cannot be collected for any reason, will remain
in the trial, and treatment will continue as outlined in the protocol.

Expected Number of Patients:

The number of patients was calculated according to the procedure described in the Sample
Size Calculation section of the protocol. It is estimated that up to 50 patients will be
enrolled to obtain the 43 evaluable patients needed to meet the statistical design of the

Method of Treatment Allocation:

A patient number will be assigned sequentially to each patient upon registration. The
patient number and the patient initials are to be entered on each page of the Case Report

Duration of Study for Each Patient:

All patients will be treated with up to 6 cycles of chemotherapy. However, at the discretion
of the treating physician and principle investigator, patients may continue chemotherapy,
beyond 6 cycles, until disease progression, intolerable toxicity, or the development of any
study removal criteria. Patients will undergo an evaluation for extent of disease after
every other treatment cycle.

Patients will be considered to be on-study for the duration of their treatment and during
the 30 days following treatment discontinuation. Treatment discontinuation is defined as the
last day of study treatment. All included patients will be followed up until recovery or
stabilization of all adverse events or return to baseline condition. Patients who
discontinue from the trial prior to experiencing disease progression will be followed
monthly until demonstration of progressive disease.

Study Centers:

The H. Lee Moffitt Cancer Center will conduct this trial through the Moffitt Clinical
Research Affiliate Network. Patients will be evaluated and the biopsy will be performed at
the H. Lee Moffitt Cancer Center. Since all the chemotherapeutic drugs used in the protocol
are FDA approved, and phase I and II safety data regarding this regimen has been
published30,31, the chemotherapy may be administered at the patients' primary (referring)
oncologists' office. Documentation of the administration of the chemotherapy will be
obtained for record keeping purposes.

Inclusion Criteria:

- 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:

1. Absolute neutrophil count (ANC) > 1,500/µL

2. Platelet count > 100,000/µL

3. Hemoglobin > 8 g/dL (determined within 2 weeks prior to enrollment)

- Adequate renal function evidenced by:

1. serum creatinine < 1.5 mg/dL OR

2. calculated creatinine clearance >45 mL/min.

- Adequate hepatic function evidenced by:

1. Serum total bilirubin < 1.5 mg/dL OR less than the upper limit of normal (ULN)

2. Alkaline phosphatase < 3X the ULN for the reference lab (< 5X the ULN for
patients with known hepatic or bony metastases)

3. SGOT/SGPT < 3X the ULN for the reference lab (< 5X the ULN for patients with
known hepatic metastases)

- Must be recovered from both acute and late effects of any prior surgery,
radiotherapy, other antineoplastic therapy

- Signed informed written consent

- Patients of childbearing potential and their partners must agree to use an effective
form of contraception during the study and for 90 days following last dose of study

Exclusion Criteria:

- 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

- 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Patients Who Responded to Treatment

Outcome Description:

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

Outcome Time Frame:

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

Safety Issue:


Principal Investigator

Alberto Chiappori, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

H. Lee Moffitt Cancer Center and Research Institute


United States: Institutional Review Board

Study ID:




Start Date:

June 2007

Completion Date:

January 2008

Related Keywords:

  • Lung Cancer
  • recurrent
  • non-small cell
  • Lung Neoplasms



H. Lee Moffitt Cancer Center and Research InstituteTampa, Florida  33612