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A Phase 2 Study Comparing Sequential Satraplatin and Erlotinib to Single-Agent Erlotinib in Patients ≥ 70 Years of Age With Unresectable Stage 3 OR 4 Non-Small Cell Lung Cancer as 1st-Line Therapy

Phase 2
70 Years
Not Enrolling
Lung Cancer

Thank you

Trial Information

A Phase 2 Study Comparing Sequential Satraplatin and Erlotinib to Single-Agent Erlotinib in Patients ≥ 70 Years of Age With Unresectable Stage 3 OR 4 Non-Small Cell Lung Cancer as 1st-Line Therapy

Erlotinib as a single-agent is currently approved for the treatment of patients with NSCLC
whose disease has progressed following one prior course of chemotherapy and is currently
being evaluated in NSCLC patients who have not received prior systemic treatment. However,
when studied with combination chemotherapy in the first-line setting, continuous daily
administration of erlotinib did not result in improved patient survival. Further clinical
and in vitro data suggest that the sequencing of cytotoxic chemotherapy with EGFR TKIs is
important to maximize their therapeutic potential when administered in combination.

Satraplatin is an orally administered platinum analogue that has shown promising
single-agent activity in multiple tumor types including prostate, ovarian, and small cell
lung cancer. Additionally, the single-agent activity of satraplatin in NSCLC is similar to
that of other commonly used platinum agents used to treat NSCLC. However, satraplatin is
better tolerated than cisplatin, causing less renal toxicity and ototoxicity, and it can be
administered in the outpatient setting. From a toxicity profile, it is more similar to
carboplatin in that myelosuppression is its dose limiting toxicity (DLT). Satraplatin is
currently being evaluated in a pivotal phase 3 clinical trial as 2nd-line therapy for
patients with hormone refractory prostate cancer.

The rationale for this study is to develop an active and well-tolerated oral regimen for
patients ≥ 70 years of age with NSCLC who may not be candidates for aggressive combination
systemic chemotherapy. Administration of the study drugs will be sequenced with satraplatin
administered on days 1-5 and erlotinib on days 8-21 of each 28-day cycle. As erlotinib has
shown an advantage in survival without a commensurate improvement in response rate, the
primary endpoint will be progression-free survival (PFS); thus patients will be randomized
to treatment with either the experimental regimen or single-agent continuous erlotinib.

Inclusion Criteria:

- Histologically or cytologically confirmed NSCLC (squamous cell carcinoma,
adenocarcinoma, or large cell carcinoma). Cytologic specimens obtained by brushings,
washings or needle biopsy with aspiration are acceptable. Mixed tumors with small
cell anaplastic elements are not eligible.

- Patients who have unresectable stage III or stage IV disease are eligible. Patients
with stage III disease should be ineligible for combined modality therapy (i.e.
pleural effusions, pericardial effusions, etc.). Patients with earlier stage NSCLC
that has recurred after prior surgery are eligible.

- Age ≥ 70 years old.

- ECOG performance status 0-1

- Prior treatment with systemic therapy is allowed provided the following criteria are

- No EGFR targeted therapy (TKI or antibody)

- No prior platinum agent.

- Neoadjuvant, adjuvant, or part of a combined modality regimen (i.e., not for
metastatic disease)

- Completion > 6 months prior to enrollment onto this study.

- Patients who have had previous radiation therapy (RT) as definitive therapy for
locally NSCLC are eligible only if the following criteria are met:

- Site of tumor recurrence is outside of the original RT port unless there is
incontrovertible evidence of disease progression within the portal

- All side effects from RT must have resolved prior to enrollment.

- Completion of RT ≥ 4 weeks prior to enrollment.

- Previous radiation must have treated < 30% of active bone marrow.

- Patients who have undergone thoracotomy must have fully recovered from surgery
and cannot start treatment until at least three weeks after their operative

- Adequate hematological function as noted by:

- Absolute neutrophil count (ANC) > 1,500/ L

- Platelets > 100,000/ L

- Hemoglobin > 10 g/dl. Patients may be transfused or receive erythropoietin to
maintain or exceed this level.

- Adequate hepatic and renal function as noted by:

- Bilirubin < 1.5 x ULN

- Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) < 2.5 x ULN.

- Serum creatinine ≤ 1.5mg/dL or calculated (or measured) glomerular filtration
rate ≥ (GFR)50 ml/min.

- Patients with both measurable and non-measurable disease (as per Response
Criteria in Solid Tumors (RECIST)) may be enrolled.

Exclusion Criteria:

- Concurrent invasive malignancy requiring ongoing therapy.

- Metastatic brain or meningeal tumors, unless the patient is > 1 month from definitive
therapy, is clinically stable with respect to the tumor at the time of study entry,
is not receiving steroid therapy or taper, and is not receiving anti-convulsant
medications (that were started for the brain metastases).

- Previous treatment with either platinum-based chemotherapy agents or prior EGFR
targeting agents.

- Peripheral neuropathy > grade 1.

- Hearing loss or tinnitus > grade 2

- Obstructive pulmonary disease or symptoms > grade 3.

- A history of cardiac disease as defined by malignant hypertension, unstable angina,
congestive heart failure, myocardial infarction within the previous six months, or
symptomatic uncontrolled cardiac arrhythmias.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To compare Progression-Free Survival (PFS) in patients ≥ 70 years of age, PS 0-1, with advanced or metastatic NSCLC in patients treated with a first-line regimen of either sequential satraplatin and erlotinib or continuous single-agent erlotinib.

Outcome Time Frame:

January, 2008

Safety Issue:


Principal Investigator

Corey Langer, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fox Chase Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

July 2006

Completion Date:

March 2009

Related Keywords:

  • Lung Cancer
  • Non Small Cell Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



Cleveland Clinic FoundationCleveland, Ohio  44195
Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
Rush University Medical CenterChicago, Illinois  60612-3824
Scripps ClinicLa Jolla, California  92037
University of Miami Sylvester Cancer CenterMiami, Florida  33136
Kenmar Research InstituteLos Angeles, California  90057
Gabrail Cancer CenterCanton, Ohio  44718
Pacific Cancer Medical CenterAnaheim, California  92801
Signal Point Hematology/OncologyMiddletown, Ohio  45042
Memorial Cancer InstitutePembroke Pines, Florida  33028
Highlands Oncology GroupBentonville, Ohio  72712