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Phase II Study Of Bevacizumab And PEG Interferon Alpha-2b (PEG Intron) In Patients With Metastatic, Or Unresectable Carcinoid Tumors

Phase 2
18 Years
Not Enrolling
Metastatic Gastrointestinal Carcinoid Tumor, Recurrent Gastrointestinal Carcinoid Tumor, Regional Gastrointestinal Carcinoid Tumor

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Trial Information

Phase II Study Of Bevacizumab And PEG Interferon Alpha-2b (PEG Intron) In Patients With Metastatic, Or Unresectable Carcinoid Tumors


I. Determine the progression-free survival rate in patients with metastatic or unresectable
carcinoid tumors treated with bevacizumab and PEG-interferon alfa-2b.

II. Determine the tumor response rate (complete and partial) in patients treated with this

III. Determine the biochemical response rate of patients treated with this regimen.

IV. Determine the qualitative and quantitative toxicity and reversibility of toxicity of
this regimen in these patients.

OUTLINE: This is a randomized study. Patients are treated in 2 stages.

Stage I: Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients receive bevacizumab IV on day 1.

Arm II: Patients receive PEG-interferon alfa-2b subcutaneously (SC) on days 1, 8, and 15.

In both arms, courses repeat every 3 weeks. Patients with progressive disease at 9 weeks
proceed to stage II. All other patients proceed to stage II after 18 weeks on stage I.

Stage II: Patients receive bevacizumab IV on day 1 and PEG-interferon alfa-2b SC once
weekly. Courses repeat every 3 weeks in the absence of disease progression or unacceptable
toxicity. Patients who achieve a complete response (CR) and remain in CR for 2 additional
courses come off study. Patients are followed for survival.

Inclusion Criteria:

- Histologically confirmed carcinoid tumor

- Metastatic or unresectable local-regional disease

- Measurable disease

- No osseous metastasis as the only site of disease

- No history or clinical evidence of CNS disease (e.g., primary brain tumor or any
brain metastasis)

- Performance status - Zubrod 0-2

- Performance status - Karnofsky 70-100%

- At least 12 weeks

- See Immunologic

- Absolute granulocyte count > 1,500/mm^3

- Platelet count > 100,000/mm^3

- Hemoglobin > 8 g/dL

- No bleeding diathesis or coagulopathy

- No hemoglobinopathies (e.g., thalassemia) or any other cause of hemolytic anemia

- Bilirubin < 1.5 mg/dL

- INR < 1.5 (if receiving warfarin)

- No evidence of decompensated liver disease (e.g., ascites, bleeding varices, or
spontaneous encephalopathy)

- Creatinine < 1.5 mg/dL

- No baseline proteinuria

- Patients with proteinuria (≥ 2+ or ≥ 100 mg/dL on urinalysis) are allowed
provided 24-hour urinary protein is < 500 mg

- No New York Heart Association grade II-IV congestive heart failure

- No serious cardiac arrhythmia requiring medication

- No clinically significant peripheral vascular disease

- No history of stroke

- None of the following within the past 6 months:

- Uncontrolled hypertension

- Transient ischemic attack

- Cerebrovascular accident

- Unstable angina

- Myocardial infarction

- No chronic pulmonary disease (e.g., chronic obstructive pulmonary disease)

- No documented pulmonary hypertension

- None of the following immunologically mediated diseases:

- Inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis)

- Rheumatoid arthritis

- Idiopathic thrombocytopenia purpura

- Systemic lupus erythematosus

- Autoimmune hemolytic anemia

- Scleroderma

- Severe psoriasis

- No serious concurrent infections

- No active infection requiring parental antibiotics on day 0

- No known hypersensitivity to Chinese hamster ovary cell products or other recombinant
human antibodies

- No known hypersensitivity to interferon alfa or to any excipient or vehicle included
in its formulation or delivery system

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No significant traumatic injury within the past 4 weeks

- No preexisting thyroid abnormality for which thyroid function can not be normalized
by medication

- No concurrent nonmalignant uncontrolled medical illness or one whose control may be
jeopardized by the complications of this study therapy

- No uncontrolled psychiatric disorder

- No psychiatric disorders that would preclude study compliance

- No other malignancy within the past 5 years except nonmelanoma skin cancer or
carcinoma in situ of the cervix

- No serious nonhealing wound ulcer or bone fracture

- No seizures not controlled with standard medical therapy

- Prior immunotherapy allowed

- No prior interferon

- No concurrent immunotherapy

- At least 4 weeks since prior chemotherapy, including radiosensitizers

- No more than 1 prior chemotherapy regimen, including radiosensitizers

- No concurrent chemotherapy

- At least 4 weeks since prior radiotherapy

- Prior radiotherapy must not have contained the single evaluable lesion of this
study in a radiation field

- No concurrent radiotherapy

- At least 4 weeks since prior major surgery or open biopsy (1 week for minor surgery)
and recovered

- No concurrent or recent full-dose anticoagulants or thrombolytic agents (except as
required to maintain patency of preexisting, permanent indwelling IV catheters)

- No concurrent chronic daily aspirin (more than 325 mg/day) or nonsteroidal
anti-inflammatory medications known to inhibit platelet function

Type of Study:


Study Design:

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

Outcome Measure:

Tumor response rate (CR + PR) as measured by RECIST criteria

Outcome Time Frame:

Up to 4 years

Safety Issue:


Principal Investigator

James Yao

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

January 2003

Completion Date:

Related Keywords:

  • Metastatic Gastrointestinal Carcinoid Tumor
  • Recurrent Gastrointestinal Carcinoid Tumor
  • Regional Gastrointestinal Carcinoid Tumor
  • Carcinoid Tumor
  • Malignant Carcinoid Syndrome
  • Gastrointestinal Neoplasms



M D Anderson Cancer Center Houston, Texas  77030