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Chemotherapy for Pancreatic Cancer

Phase 2

Recruiting

Led By Heloisa P Soares

Research Sponsored by SWOG Cancer Research Network

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Gastrointestinal bleed

Participants must have a scan within 90 days prior to registration without evidence of metastatic disease. Acceptable scans are multiphase computed tomography (CT) abdomen, magnetic resonance imaging (MRI) with intravenous (IV) contrast of the abdomen, or positron emission tomography (PET)-CT DOTATATE imaging if the DOTATATE PET-CT included IV iodine contrast for the CT portion of the exam

Must not have

Participants must not have clinically apparent central nervous system metastases or carcinomatous meningitis

Participants must not have history of allergic reactions attributed to compounds of similar chemical or biologic composition to temozolomide or capecitabine

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from date of registration to date of death due to any cause, assessed up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial looks at giving capecitabine & temozolomide after surgery to patients with a certain kind of pancreatic tumor. These drugs work in different ways to stop the growth of tumor cells. This could prevent or delay the return of cancer in these patients.

Who is the study for?

This trial is for adults who've had surgery for high-risk, well-differentiated pancreatic neuroendocrine tumors. They must be able to swallow pills, have no other active cancers (with some exceptions), and not have received certain treatments post-surgery. A complete medical history and physical exam are required, along with specific blood count and chemistry levels.

What is being tested?

The trial tests the effectiveness of two chemotherapy drugs, capecitabine and temozolomide, given after surgery to prevent cancer from returning in patients with high-risk pancreatic neuroendocrine tumors. The study will observe how these drugs stop tumor cells from growing or spreading.

What are the potential side effects?

Capecitabine may cause side effects like diarrhea, hand-foot syndrome (redness/pain/swelling of hands/feet), nausea, vomiting; while temozolomide can lead to fatigue, headache, constipation/diarrhea. Both drugs might also lower blood cell counts increasing infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had bleeding in my stomach or intestines.

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I've had a recent scan showing no signs of cancer spread.

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I have a blockage in my digestive tract.

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I am 18 years old or older.

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My surgery removed all visible cancer, or nearly all.

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I can take care of myself and am up and about more than 50% of my waking hours.

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I experienced pain from my tumor before it was surgically removed.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have cancer spread to my brain or its coverings.

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I have no allergies to medications similar to temozolomide or capecitabine.

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I do not have problems absorbing medications.

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I am not planning to take warfarin during the treatment.

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I do not have any ongoing or uncontrolled infections.

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I do not have untreated metastatic cancer.

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I have not had pre-surgery treatment for pancreatic neuroendocrine tumor, but may have used somatostatin analogs.

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I haven't taken somatostatin analogs after my surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from date of registration to date of death due to any cause, assessed up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from date of registration to date of death due to any cause, assessed up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of registration to date of death due to any cause, assessed up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Recurrence-free survival (RFS)

Secondary study objectives

Incidence of adverse events

Overall survival (OS)

Side effects data

From 2021 Phase 3 trial • 693 Patients • NCT02028507

63%

Neutrophil count decreased

51%

Fatigue

37%

Hypertension

25%

Nausea

23%

Weight loss

19%

Back pain

17%

Diarrhea

17%

Headache

17%

Mucositis

16%

Weight gain

15%

Vomiting

13%

Hypothermia

13%

Arthralgia

12%

Anorexia

12%

Alopecia

11%

Anemia

11%

Cough

11%

Upper respiratory infection

10%

Obesity

10%

Flu like symptoms

Pain in extremity

Constipation

Fever

Bone pain

Dizziness

Dyspepsia

Hot flashes

Pruritus

Pain

Dysgeusia

Abdominal pain

Respiratory infection

Nail disorder

Spinal cord compression

Heart failure

Pleural effusion

Ascites

Breast infection

Dyspnea

Gallbladder infection

Renal failure

Dislocation of hip

Bronchial infection

Urinary tract infection

Thromboembolic event

Osteonecrosis of jaw

Palmar-plantar erythrodysesthesia syndrome

Cholecystitis acute

Gastrointestinal infection

100%

80%

60%

40%

20%

Study treatment Arm

Cohort 2: Palbociclib Plus Fulvestrant

Cohort 1 and 2: Capecitabine

Cohort 1: Palbociclib Plus Exemestane

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm I (capecitabine, temozolomide)Experimental Treatment2 Interventions

Patients receive capecitabine PO BID on days 1-14 and temozolomide PO once QD on days 10-14. Treatment repeats every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.

Group II: Arm II (surveillance)Active Control1 Intervention

Patients undergo surveillance with no active treatment.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Temozolomide

2010

Completed Phase 3

~1880

Capecitabine

2013