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A Phase I-II, Multicenter, Open-label Trial of Co-administered CHR-2797 and Erlotinib in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer

Phase 1/Phase 2
18 Years
Not Enrolling
Carcinoma, Non-Small-Cell Lung

Thank you

Trial Information

A Phase I-II, Multicenter, Open-label Trial of Co-administered CHR-2797 and Erlotinib in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer

Study Phase A:

Maximum tolerated dose will be determined during Cycle 1. Tumor assessments will be made
after Cycle 2 (56 days), although it is not mandatory for Phase A patients to have
measurable disease. Patients who have satisfactory outcomes after Cycle 2 may continue
treatment for up to a year with erlotinib 150 mg/day, and the dose of CHR-2797 they received
in Study Phase A.

Study Phase B:

Patients will be treated with the dose of CHR-2797 selected in Study Phase A and 150mg/day
erlotinib. Patients will receive 2 cycles of treatment (56 days) before efficacy assessment.
Patients who have complete response, partial response, or stable disease are eligible to
continue the study for up to a year until disease progression or unacceptable toxicity. If a
patient has complete response, partial response, or stable disease at the end of the 1-year
study period and the Investigator believes that continuation treatment would be beneficial,
the patient may continue to be treated at the dose of CHR-2797 under a separate protocol.

Inclusion Criteria:

1. Histologically and/or pathologically confirmed NSCLC (cytologic specimens obtained by
brushing, washing, or needle aspiration of a defined lesion are acceptable). This
includes the histologic subtypes of squamous cell, adeno, large cell, anaplastic
cell, bronchioalveolar carcinoma, and NSCLC not otherwise specified (NOS). Note that
tumors with the presence of small cell anaplastic elements are not eligible

2. NSCLC with documentation of Stage IIIB (with pleural effusion), or Stage IV, or
recurrent metastatic disease based on current TNM classification

3. Disease progression or relapse following failure of platinum-based chemotherapy

4. For Study Phase A, patients are not required to have measurable disease (according to
RECIST criteria) for enrollment. For patients in Study Phase B, patients must have
measurable disease according to RECIST, defined by at least 1 lesion that can be
accurately measured. All other lesions (e.g., pleural effusions) including small
lesions (<1 cm×1 cm by spiral CT scan) are considered non-measurable for the purposes
of this study. Baseline tumor measurements are to be completed as close as possible
to, but no longer than 14 days before the start of study treatment

5. Prior radiation to the measurable site(s) of disease is not allowed, unless disease
progression has been documented at that site since the radiotherapy. Patients who
have had extensive radiotherapy are also excluded, because of the associated
myelosuppressive effect

6. Prior surgery is allowed, provided it was completed at least 4 weeks prior to
enrollment and the patient has recovered from surgery.

7. No known prior primary brain, metastatic brain, or meningeal tumors or clinical signs
or symptoms of brain metastases

8. Able to understand and willing to sign an informed consent document

9. Age ≥18 years

10. Predicted life expectancy >3 months

11. Eastern Cooperative Oncology Group (ECOG) performance status score ≤2

12. Laboratory values within the normal or reasonable ranges and, specifically,adequate
bone marrow, hepatic, and renal function including the following:

- Hemoglobin >10 g/dL, absolute neutrophil count (ANC)>1.5×109/L, platelets

- Total bilirubin ≤1.5× upper limit normal (ULN)

- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <2.5×ULN or
<5×ULN in patients with documented liver metastases

- Creatinine ≤1.5×ULN or calculated creatinine clearance ≥60 mL/min

13. Female patients with reproductive potential must have a negative serum pregnancy test
within 72 hours prior to start of study medication. All female patients of
childbearing potential, and all male patients, must agree to use a medically
acceptable method of contraception or agree to be abstinent throughout the treatment
period and for 3 months after discontinuation of treatment. (See Section 4.1for more

14. Screening for LVEF >= 55%

Exclusion Criteria:

1. Excluded therapies:

- Concurrent anti-cancer therapy

- Treatment with cytotoxic agents within the last 3 or 4 weeks, depending on the
usual frequency of administration of the regimen, or within the last 6 weeks for
agents such as mitomycin. Patients must have had resolution of acute
treatment-related toxicities to baseline or National Cancer Institute Common
Toxicity Criteria (NCI-CTC) Grade <1, with the exception of alopecia

- Therapy within the last 28 days or while on study with another investigational

- Use of biological response modifiers, such as granulocyte-colony stimulating
factor (G-CSF) or erythropoietin, within 28 days of enrollment

- Prior therapy with an epidermal growth factor receptor (EGFR) inhibitor

- Radiation to the site(s) of measurable disease, unless disease progression has
been documented at that site since the radiotherapy.

- Need for palliative radiotherapy of indicator lesions

- Treatment with known strong CYP3A4 inhibitors, for example '- azole antifungals,
protease inhibitors, erythromycin, clarithromycin within 2 weeks of enrollment
or at any time during the study

- Treatment with strong CYP3A4 inducers such as rifampicin, rifabutin or
rifapentine within 2 weeks of enrollment or at any time during the study

- Warfarin or doses of coumadin (or equivalent) that are higher than 1mg/day

2. Excluded medical conditions:

- Current hematological malignancy

- Gastro-intestinal abnormalities including:

- Inability to take oral medication

- Requirement for intravenous (IV) alimentation

- Malabsorption syndrome

- Active peptic ulcer disease

- A serious uncontrolled medical disorder or active infection which would impair
their ability to receive study treatment

- Known primary brain, metastatic brain, or meningeal tumors, or clinical signs or
symptoms of brain metastases

- Second malignancy (except adequately treated basal cell carcinoma of the skin or
in-situ carcinoma of the cervix or breast)

- Known history of human immunodeficiency virus (HIV) infection or chronic
hepatitis B or C

- Uncontrolled hypercalcemia (>NCI-CTC Grade 1)

- Significant cardiovascular disease including but not limited to the following:

- History (past or present) of congestive heart failure

- History (past or present) of angina pectoris requiring medication

- History of myocardial infarction with past 12 months

- Presence of clinically significant valvular heart disease

- History (past or present) of arrhythmia requiring treatment

- Presence of conduction defect on Screening ECG

- History (past or present) of uncontrolled hypertension

- Patients with interstitial lung disease

3. Major surgery within 4 weeks prior to enrollment

4. >20% weight loss in previous 3 months

5. Pregnant or lactating women

6. Known rapidly deteriorating liver function tests (2×ULN rise in 1 week)

7. Dementia or significantly altered mental status that would prohibit the understanding
or rendering of informed consent and/or compliance with the requirements of the

8. Known or suspected allergy to any study medication used in this study

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Study Phase A- To determine the safety, tolerability, and maximum tolerated dose (MTD) of CHR-2797 when co-administered with erlotinib

Outcome Time Frame:

end of study

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

December 2007

Completion Date:

April 2008

Related Keywords:

  • Carcinoma, Non-Small-Cell Lung
  • Lung
  • Cancer
  • Non-small
  • Lung Cancer
  • erlotinib
  • oral
  • Locally Advanced Non-small Cell Lung Cancer
  • Metastatic Non-small Cell Lung Cancer
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



Montefiore Medical Center Bronx, New York  10467-2490
Medical Oncology Care Associates Orange, California  92668
Tower Cancer Research Foundation Beverly Hills, California  90211
Carolina BioOncology Institute Huntersville, North Carolina  28078
Richmond University Medical Center Staten Island, New York  10310-1699
Oncology Associates of West Kentucky Paducah, Kentucky  42003
Clinworks Research Center Charlotte, North Carolina  28207