Know Cancer

or
forgot password

Multi Center, Open Label, Single Arm Trial Evaluating Panitumumab in Combination With FOLFIRI Therapy Following First Line FOLFOX and Bevacizumab Treatment of Metastatic Colorectal Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Colon Cancer, Colorectal Cancer, Rectal Cancer, Cancer, Metastatic Cancer, Metastatic Colorectal Cancer, Oncology

Thank you

Trial Information

Multi Center, Open Label, Single Arm Trial Evaluating Panitumumab in Combination With FOLFIRI Therapy Following First Line FOLFOX and Bevacizumab Treatment of Metastatic Colorectal Cancer


Inclusion Criteria:



- Diagnosis of metastatic adenocarcinoma of the colon or rectum

- Available paraffin-embedded tumor tissue

- Failure of first line treatment containing fluoropyrimidine and oxaliplatin based
chemotherapy with bevacizumab for mCRC

- Measurable disease

- Adequate hematologic, renal, hepatic and metabolic function

Exclusion Criteria:

- Radiotherapy ≤ 2 weeks prior to Day 1 of Cycle 1

- Unresolved toxicity(ies) from prior anti cancer therapy that, in the opinion of the
investigator, precludes the subject from study enrollment

- Prior irinotecan therapy. anti EGFr therapy, or vaccine for the treatment of mCRC

- CYP3A4 enzyme inducers, inhibitors, and substrates (eg, phenytoin, phenobarbital,
carbamazepine, ketoconazole, rifampin, rifabutin, and St. John's Wort) ≤ 2 weeks
prior to Day 1 of Cycle 1

- Infection requiring systemic anti infectives completed ≤ 2 weeks prior to Day 1 of
Cycle 1

- Clinically significant cardiovascular disease

- History of interstitial lung disease (eg, pneumonitis or pulmonary fibrosis)

- Pulmonary embolism, deep vein thrombosis, or other significant thromboembolic event ≤
8 weeks prior to Day 1 of Cycle 1

- Any significant bleeding ≤6 weeks prior to Day 1 of Cycle 1, per the investigator's
judgement

- Gastroduodenal ulcer(s) determined by endoscopy to be active or uncontrolled
gastrointestinal ulcer ≤ 4 weeks prior to Day1 of Cycle 1

- Any co morbid disease or condition that could increase the risk of toxicity (eg,
dihydropyrimidine deficiency, significant ascites, or pleural effusion)

- Major surgery (requiring general anesthesia), open biopsy, or significant traumatic
injury ≤4 weeks prior to Day1 of Cycle 1. Subjects must have recovered from surgery
and have no significant complications

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective response rate at weeks 17 and 25, and best response rate; progressions-free survival at weeks 17 and 25; progression free survival time; disease control; duration of objective response; overall survival

Safety Issue:

Yes

Principal Investigator

MD

Investigator Role:

Study Director

Investigator Affiliation:

Amgen

Authority:

United States: Food and Drug Administration

Study ID:

20060277

NCT ID:

NCT00411450

Start Date:

December 2006

Completion Date:

October 2010

Related Keywords:

  • Colon Cancer
  • Colorectal Cancer
  • Rectal Cancer
  • Cancer
  • Metastatic Cancer
  • Metastatic Colorectal Cancer
  • Oncology
  • k-ras
  • biomarker
  • colorectal
  • colon
  • rectal
  • FOLFOX
  • FOLFIRI
  • Colonic Neoplasms
  • Rectal Neoplasms
  • Colorectal Neoplasms
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary

Name

Location