SPIRITT - Second-Line Panitumumab Irinotecan Treatment Trial

NCT00418938 | Completed Phase 2 Results DMC

• 1 other identifier: 20060141
• Study Type: interventional
• Target: 266
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a multi-center, open-label, randomized, phase 2, two-arm clinical trial to be conducted in the United States. Approximately 210 eligible KRAS wild-type expressing metastatic colorectal cancer subjects who have failed first-line oxaliplatin-based chemotherapy (with at least 4 doses of oxaliplatin-based chemotherapy) with at least 4 doses of bevacizumab (failure is defined as toxicity due to oxaliplatin-based chemotherapy or progression of disease on first-line treatment) will be randomized in a 1:1 ratio to receive either a once-every-two-weeks (Q2W) FOLFIRI regimen plus panitumumab 6 mg/kg or a Q2W FOLFIRI regimen plus bevacizumab (either 5 mg/kg or 10 mg/kg, depending on physician choice and institutional standard of care).

Conditions

Cancer; Colon Cancer; Colorectal Cancer; Metastatic Cancer; Rectal Cancer; Metastatic Colorectal Cancer

Keywords

EGFR; FOLFIRI; 2nd Line Therapy; 2nd Line mCRC Therapy; mCRC; Irinotecan; panitumumab; bevacizumab

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival (PFS)

  Progression-free survival is defined as time from the date of randomization to the date of first progression per modified RECIST version 1.0 (based on central review of the radiographic scans), or death within 60 days after the last evaluable tumor assessment or randomization date (whichever is later).

  From randomization up to 65 months.

Secondary Outcomes (6)

• Overall Survival

  From randomization up to 65 months.

• Objective Response Rate

  From randomization up to 65 months.

• Time to Response

  From randomization up to 65 months.

• Time to Progression

  From randomization up to 65 months.

• Disease Control

  From randomization up to 65 months.

Study Arms (2)

Arm A

EXPERIMENTAL

FOLFIRI + Panitumumab

Drug: Panitumumab; Drug: Leucovorin; Drug: Irinotecan; Drug: 5-Fluorouracil

Arm B

EXPERIMENTAL

FOLFIRI + Bevacizumab

Drug: Bevacizumab; Drug: Leucovorin; Drug: Irinotecan; Drug: 5-Fluorouracil

Interventions

Panitumumab DRUG

6mg/kg IV

Arm A

Bevacizumab DRUG

Either 5mg/kg OR 10mg/kg IV

Arm B

Leucovorin DRUG

400mg/m\^2 IV (in the vein)

Arm A; Arm B

Irinotecan DRUG

180mg/m\^2 IV (in the vein)

Arm A; Arm B

5-Fluorouracil DRUG

400mg/m\^2 bolus IV (in the vein) over 2-4 min, followed by 2400mg/m\^2 continuous IV over 46 hours for the first 2 cycles, increased to 3000mg/m\^2 thereafter if no significant side effects

Arm A; Arm B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of metastatic adenocarcinoma of the colon or rectum that cannot, in the opinion of the investigator, be cured by surgical resection at the time of randomization
• Wild-type KRAS expressing mCRC from the primary tumor or metastasis.
• Failure of prior first-line oxaliplatin-based chemotherapy with bevacizumab (at least four therapeutic doses of oxaliplatin-based chemotherapy and bevacizumab) for mCRC.
• At least one uni-dimensionally measurable lesion per modified RECIST criteria.
• Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Man or woman 18 years of age or older
• Hematology, chemistry, coagution, metabolic functions within normal or protocol-defined limits

You may not qualify if:

• Previous irinotecan, anti-EGFr therapy (eg, cetuximab, panitumumab, erlotinib, gefitinib, lapatinib) or vaccine for the treatment of mCRC
• Radiotherapy ≤ 14 days before randomization
• Evidence of central nervous system (CNS) metastases
• Unresolved toxicities from prior anti-cancer therapy that, in the opinion of the investigator, precludes subject from participation
• History of other invasive primary cancer, except:
• Curatively resected or treated non-melanomatous skin cancer
• Curatively treated cervical carcinoma in situ
• Other primary solid tumor treated curatively and no treatment administered ≤ 2 years before randomization and, in the investigator's opinion, it is unlikely that there will be a recurrence ≤ 2 years post randomization
• Medications
• C hronic daily treatment (as determined by the investigator) with aspirin (\> 325 mg/day) or non steroidal anti inflammatory agents known to inhibit platelet function
• Infection requiring a course of systemic anti-infectives that was completed ≤ 14 days before randomization (exception can be made at the judgment of the investigator for oral treatment of an uncomplicated urinary tract infection \[UTI\])
• Subjects concurrently receiving any investigational agent or therapy ≤ 30 days before randomization
• General:
• Significant cardiovascular risk as defined by the protocol
• History of peripheral arterial ischemia ≤ 24 weeks before randomization (subjects with brief, reversible, exercise-induced claudication are eligible)

Sponsors & Collaborators

• Amgen: lead

Related Publications (1)

• Hecht JR, Cohn A, Dakhil S, Saleh M, Piperdi B, Cline-Burkhardt M, Tian Y, Go WY. SPIRITT: A Randomized, Multicenter, Phase II Study of Panitumumab with FOLFIRI and Bevacizumab with FOLFIRI as Second-Line Treatment in Patients with Unresectable Wild Type KRAS Metastatic Colorectal Cancer. Clin Colorectal Cancer. 2015 Jun;14(2):72-80. doi: 10.1016/j.clcc.2014.12.009. Epub 2015 Jan 8.

  PMID: 25982297 BACKGROUND

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Neoplasms; Colonic Neoplasms; Colorectal Neoplasms; Neoplasm Metastasis; Rectal Neoplasms

Interventions

Panitumumab; Bevacizumab; Leucovorin; Irinotecan; Fluorouracil

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Coenzymes; Enzymes and Coenzymes; Camptothecin; Alkaloids; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Study Director
• Organization: Amgen Inc.

866-572-6436

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2007
• First Posted: January 5, 2007
• Study Start: November 1, 2006
• Primary Completion: May 10, 2012
• Study Completion: April 1, 2013
• Last Updated: October 17, 2018
• Results First Posted: March 28, 2014

Record last verified: 2018-09