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Antimetabolite

Chemotherapy + Rucaparib for Digestive System Cancers

Phase 1 & 2

Waitlist Available

Led By Tanios S Bekaii-Saab

Research Sponsored by Academic and Community Cancer Research United

Eligibility Criteria Checklist

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

Must have

Patients with metastatic disease from gastroesophageal cancer who received no more than 1 line of prior therapy in the metastatic setting

Patients with metastatic disease from pancreatic cancer who received no more than 2 lines of prior therapy in the metastatic setting

Must not have

Inability to swallow

Nursing individuals

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying the side effects of a combination of drugs, liposomal irinotecan, rucaparib, fluorouracil, and leucovorin calcium, in treating patients with pancreatic, colorectal, gastroesophageal, or biliary cancer that has spread to other places in the body.

Who is the study for?

This trial is for adults with certain metastatic cancers (pancreatic, colorectal, gastroesophageal, or biliary) who've had limited prior treatments. They must have a good performance status and adequate organ function. Pregnant or nursing individuals can't join, nor those with HIV on antiretrovirals, other recent cancers, severe diseases that could interfere with the study, or if they've had specific treatments like PARP inhibitors.

What is being tested?

The trial tests liposomal irinotecan and rucaparib combined with fluorouracil and leucovorin calcium to see how well they treat metastatic digestive system cancers. It aims to find the best dose of these drugs together while assessing their effectiveness against tumor growth.

What are the potential side effects?

Potential side effects include nausea, vomiting, diarrhea from chemotherapy drugs; fatigue; blood count changes; liver enzyme alterations; allergic reactions; and fertility issues due to rucaparib. There's also a risk of heart rhythm problems (QTc prolongation).

Eligibility Criteria

Inclusion Criteria

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

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I have gastroesophageal cancer and received only one prior treatment for it in the metastatic stage.

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I have pancreatic cancer with metastasis and received 2 or fewer treatments.

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I have biliary tract cancer with metastasis and received only one prior treatment.

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I have colorectal cancer that has spread, and I've had up to 3 treatments for it.

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I am currently using a progesterone-only contraceptive like Depo Provera, Implanon, or Nexplanon.

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I have pancreatic cancer with specific genetic markers and haven't had treatment for it in its advanced stage.

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I am fully active or restricted in physically strenuous activity but can do light work.

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I stopped my previous chemotherapy more than 28 days ago.

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My fallopian tubes are surgically blocked.

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My cancer can be measured by tests.

Exclusion Criteria

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

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I cannot swallow.

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I am currently breastfeeding.

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I am immunocompromised or HIV positive and on antiretroviral therapy.

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I do not have any serious illnesses or social situations that would stop me from following the study's requirements.

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I am not on any experimental drugs for my cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 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

Number of Participants With Dose Limiting Toxicities (Phase I)

Secondary study objectives

Disease control rate (DCR)

Incidence of adverse events (Phase II)

Overall survival (Phase II)

+1 more

Side effects data

From 2022 Phase 3 trial • 564 Patients • NCT01968213

76%

Nausea

70%

Combined Asthenia/Fatigue

52%

Fatigue

39%

Combined Anaemia and/or decreased hemoglobin

38%

Constipation

38%

Vomiting

37%

Anaemia

35%

Diarrhoea

35%

Alanine aminotransferase increased

34%

Combined ALT/AST increased

33%

Abdominal pain

31%

Dysgeusia

29%

Combined Thrombocytopenia and/or decreased platelets

27%

Aspartate aminotransferase increased

25%

Decreased appetite

23%

Asthenia

22%

Arthralgia

20%

Headache

19%

Combined Neutropenia and/or decreased ANC

19%

Photosensitivity reaction

18%

Cough

17%

Thrombocytopenia

17%

Blood creatinine increased

16%

Dyspepsia

16%

Insomnia

16%

Dizziness

15%

Pruritus

15%

Rash

15%

Dyspnoea

15%

Abdominal pain upper

15%

Back pain

15%

Pyrexia

14%

Platelet count decreased

14%

Neutropenia

13%

Abdominal distension

13%

Upper respiratory tract infection

12%

Hypertension

12%

Oedema peripheral

12%

Hypomagnesaemia

10%

Nasopharyngitis

10%

Alopecia

10%

Taste disorder

10%

Dry skin

10%

Urinary tract infection

Mucosal inflammation

Influenza

Depression

Stomatitis

Erythema

Neutrophil count decreased

Hypercholesterolaemia

Anxiety

Dry mouth

Weight decreased

Myalgia

Oropharyngeal pain

White blood cell count decreased

Gastrooesophageal reflux disease

Influenza like illness

Hot flush

Neck pain

Pain in extremity

Blood alkaline phosphatase increased

Muscle spasms

Sinusitis

Combined Anemia and/or low hemoglobin

General physical health deterioration

Incarcerated hernia

Intestinal obstruction

Sepsis

Muscular weakness

Combined Thrombocytopenia and/or low platelets

Osteoarthritis

Gastrointestinal pain

Pulmonary embolism

Febrile neutropenia

Pancytopenia

Small intestinal obstruction

Dehydration

Combined Netropenia and/or low ANC

Malignant melanoma

Malignant neoplasm progression

Myelodysplastic syndrome

Seizure

Acute kidney injury

Renal failure

100%

80%

60%

40%

20%

Study treatment Arm

Rucaparib 600 mg Tablets

Placebo Tablets

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (nal-IRI, leucovorin, fluorouracil, rucaparib)Experimental Treatment5 Interventions

PHASE Ia: Patients receive liposomal irinotecan IV over 90 minutes, leucovorin calcium IV, and fluorouracil IV over 46 hours on days 1 and 15. Patients also receive rucaparib PO BID on days 4-13 and 18-27. Cycles repeat every 28 days in the absence of disease progression or unaccepted toxicity. PHASE Ib/II: Patients receive liposomal irinotecan IV over 90 minutes and fluorouracil IV over 46 hours on days 1 and 15. Patients also receive rucaparib PO BID on days 4-13 and 18-27. Cycles repeat every 28 days in the absence of disease progression or unaccepted toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Irinotecan Sucrosofate

2021

Completed Phase 2

~10

Leucovorin Calcium

2011

Completed Phase 3

~12500