Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Global, Multi-center, Open-label, Phase 2 Study of AGS-1C4D4 Given in Combination With Gemcitabine in Subjects With Metastatic Pancreatic Cancer
Brief Summary: A study to evaluate AGS-1C4D4 administered in combination with Gemcitabine chemotherapy in subjects with Metastatic Pancreatic Cancer.


Options:
A: DISEASE CHARACTERISTICS:

* Histologically\* or cytologically confirmed pancreatic adenocarcinoma meeting 1 of the following criteria:

  * Locally advanced unresectable disease
  * Distant metastatic disease NOTE: If diagnosis is based on a metastatic site the histology must be compatible with pancreatic cancer
* Measurable or nonmeasurable disease by x-ray, scan, or physical examination
* Tumor tissue must be submitted for evaluation of epidermal growth factor receptor expression before study entry
* None of the following tumor types are allowed:

  * Endocrine tumors
  * Lymphoma of the pancreas
  * Ampullary cancer
* No known brain metastases

PATIENT CHARACTERISTICS:

Age

* Not specified

Performance status

* Zubrod 0-2

Life expectancy

* At least 3 months

Hematopoietic

* Absolute granulocyte count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3

Hepatic

* Bilirubin no greater than 2.0 times upper limit of normal (ULN)
* SGOT or SGPT no greater than 2.5 times ULN

Renal

* Creatinine no greater than 2.0 mg/dL

Cardiovascular

* No significant history of cardiac disease
* No uncontrolled hypertension
* No unstable angina
* No uncontrolled arrhythmia
* No congestive heart failure

Other

* Not pregnant or nursing
* Fertile patients must use effective contraception
* HIV negative
* No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer that is currently in remission

PRIOR CONCURRENT THERAPY:

Biologic therapy

* No prior immunotherapy for advanced pancreatic cancer
* No prior cetuximab or other therapy that targets the epidermal growth factor pathway
* No prior chimerized or murine monoclonal antibody therapy
* No other concurrent anticancer immunotherapy

Chemotherapy

* At least 6 months since prior adjuvant chemotherapy
* No prior chemotherapy or chemoradiotherapy for advanced pancreatic cancer
* No prior gemcitabine
* No other concurrent anticancer chemotherapy

Endocrine therapy

* No prior hormonal therapy for advanced pancreatic cancer
* No concurrent anticancer hormonal therapy

Radiotherapy

* See Chemotherapy
* At least 28 days since prior radiotherapy and recovered
* Prior palliative radiotherapy to metastatic sites allowed
* No concurrent anticancer radiotherapy, including whole brain radiotherapy for progressive disease (i.e., CNS metastasis)

Surgery

* At least 14 days since prior pancreatic cancer surgery and recovered

Other

* No other concurrent anticancer therapy
B: Inclusion Criteria:

* Pathologically confirmed metastatic adenocarcinoma of the pancreas (AJCC Stage IV). Subjects with islet cell neoplasms are excluded
* Non-measurable or measurable disease based on the RECIST criteria
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
* Life expectancy of \> 3 months
* Hematologic function, as follows:

  * Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
  * Platelet count ≥ 100 x 109/L
  * Hemoglobin ≥ 9 g/dL (transfusion independent)
* Renal function, as follows:

  * Creatinine ≤ 2.0 mg/dL
* Hepatic function, as follows:

  * Aspartate aminotransferase (AST) ≤ 2.5 x ULN or ≤ 5 x ULN if known liver metastases.
  * Alanine aminotransferase (ALT) ≤ 2.5 x ULN or ≤ 5 x ULN if known liver metastases
  * Bilirubin ≤ 2 x ULN
* INR \< 1.3 (or ≤ 3 if on warfarin for therapeutic anti-coagulation)

Exclusion Criteria:

* Prior systemic therapy for metastatic pancreatic cancer

  * Subjects who have received adjuvant treatment with gemcitabine and who had relapse metastatically are allowed
  * Subjects with advanced local disease who have received treatment with gemcitabine and in whom progression has been observed with the onset of metastases less than 6 months are excluded
* Chemotherapy and/or radiation within 4 weeks of study enrollment
* Prior monoclonal antibody therapy within 60 days of study enrollment
* Known brain or leptomeningeal disease
* History of other primary malignancy, unless:

  * Curatively resected non-melanomatous skin cancer
  * Other malignancy curatively treated with no known active disease present and no treatment administered for the last 3 years
* Active angina or Class III or IV Congestive Heart Failure (New York Heart Association CHF Functional Classification System)
* Use of any investigational product within 4 weeks of study enrollment
* Major surgery (that requires general anesthesia) within 4 weeks before study enrollment
* Women who are pregnant (confirmed by positive pregnancy test) or lactating
* Man or woman of childbearing potential not consenting to use adequate contraceptive precautions during the course of the study and for 4 weeks after the last AGS-1C4D4 and/or gemcitabine infusion administration
* Subject known to be human immunodeficiency, hepatitis B or hepatitis C virus positive
* Active serious infection not controlled with antibiotics
C: Inclusion Criteria:

* Histologically confirmed adenocarcinoma of the pancreas that is surgically inoperable
* Must have had one prior chemotherapeutic regimen for advanced disease (Prior radiation with a radiation sensitizer for locally advanced disease or adjuvant therapy is not considered a prior regimen for purpose of this study)
* Disease must be measurable by RECIST criteria; measurable disease will be defined as at least one lesion that can be accurately measured in at least one dimension measuring at least 2 cm conventional CT or MRI or 1 cm with spiral CT scans (Appendix A)
* Aged 18 years or older
* ECOG performance status of 0 - 2 (see Appendix B)
* Able to take oral medications without difficulty
* Adequate bone marrow function as evidenced by an ANC \> 1500/mL and platelet count \> 100, 000/mL
* Adequate renal function as evidenced by serum creatinine within institutional limits or creatinine clearance \> 60 ml/minute if above upper institutional limits (ULN)
* Adequate hepatic function as evidenced by ALT, AST, and total bilirubin within ULN. If hepatic metastases are present, ALT and AST may be up to 5 x ULN.
* Provision of written informed consent
* Men and women of childbearing potential must be willing to practice acceptable methods of birth control to prevent pregnancy. This is a precautionary measure for use of Gefitinib and docetaxel.

Exclusion Criteria:

* Known severe hypersensitivity to Gefitinib or docetaxel or any of the excipients of these products (i.e. polysorbate 80)
* Previous treatment with Gefitinib or docetaxel.
* Other coexisting malignancies or malignancies diagnosed within the last 5 years, with the exception of basal cell carcinoma or squamous cell carcinoma of the skin or cervical cancer in situ.
* Concomitant use of phenytoin, carbamazepine, barbiturates, rifampicin, phenobarbital, or St John's Wort
* Treatment with a non-approved or investigational drug within 30 days before Day 1 of trial treatment.
* Treatment with radiation therapy or chemotherapy within 28 days before Day 1 of trial treatment
* Any unresolved chronic toxicity greater then CTC grade 2 from previous anticancer therapy (except alopecia)
* Incomplete healing from previous oncologic or other major surgery.
* Pregnancy or breast feeding (women of childbearing potential).
* Any evidence of clinically active interstitial lung disease (patients with chronic stable radiographic changes who are asymptomatic need not be excluded).
* As judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease).
* Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the trial.
D: DISEASE CHARACTERISTICS:

* Histologically or cytologically confirmed adenocarcinoma of the pancreas

  * No other pancreatic tumor type, including either of the following:

    * Neuroendocrine tumor
    * Ampulla of Vater carcinoma
  * Metastatic disease
* Measurable or evaluable disease
* Unresectable disease, defined as either of the following:

  * Failed prior attempt of surgical resection by laparotomy
  * Surgical resection contraindicated by radiographic criteria (e.g., arterial vascular invasion)
* No cerebral metastases

PATIENT CHARACTERISTICS:

Age

* 18 to 75

Performance status

* Karnofsky 70-100%

Life expectancy

* Not specified

Hematopoietic

* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3

Hepatic

* Bilirubin \< 1.5 times upper limit of normal
* No hepatic disturbance

Renal

* Creatinine \< 120 mmol/L

Cardiovascular

* No untreated cardiac or coronary insufficiency
* No uncontrolled symptomatic arrhythmia
* No uncontrolled angina

Pulmonary

* No uncontrolled respiratory insufficiency

Other

* Not pregnant or nursing
* Fertile patients must use effective contraception
* No other malignancy except basal cell skin cancer or carcinoma in situ of the cervix
* No peripheral neuropathy ≥ grade 2
* No ongoing active infection
* No other serious uncontrolled medical disorder that would preclude study treatment

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* No prior chemotherapy

Endocrine therapy

* Not specified

Radiotherapy

* No prior radiotherapy to the celiac or pancreatic area

Surgery

* See Disease Characteristics

Answer: B