CAPOX in KRAS Wild-Type Advanced Adenocarcinoma of the Small Bowel or Ampulla of Vater
Verified July 2015 by M.D. Anderson Cancer Center
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
First received: September 14, 2010
Last updated: July 15, 2015
Last verified: July 2015
The goal of this clinical research study is to learn if panitumumab can help to control advanced cancer of the small bowel or ampulla of Vater. The safety of this drug will also be studied.
||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Phase II Study of Panitumumab in KRAS Wild-type Locally Advanced or Metastatic Adenocarcinoma of the Small Bowel or Ampulla of Vater
Primary Outcome Measures:
- Response Rate (RR) of Patients [ Time Frame: After 4, 14 day cycles ] [ Designated as safety issue: Yes ]
The primary endpoint of this phase II, single arm study is response rate (RR) for patients treated with single-agent Panitumumab.
Patients evaluated for up to 8 cycles from their first dose, and a patient will be considered as a non-responder if no partial response (PR) or complete response (CR) has been documented after 8 cycles of treatment. Response and progression evaluated using new international RECIST criteria (version 1.1, 2009) proposed by RECIST committee. All patients who have measurable disease according to the RECIST criteria and who have their disease re-evaluated are evaluable for response.
| Estimated Enrollment:
| Study Start Date:
| Estimated Primary Completion Date:
||November 2016 (Final data collection date for primary outcome measure)
Starting Dose of Panitumumab: 9 mg/kg by vein over 60 minutes on day 1 of a 14 day cycle.
Starting Dose Level: 9 mg/kg by vein over 60 minutes on day 1 of a 14 day cycle.
Other Name: Vectibix
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Patients must have histologically confirmed adenocarcinoma of the small bowel or ampulla of Vater that is either unresectable or metastatic.
- Adequate tumor tissue available for KRAS mutational analysis or known KRAS wild-type status.
- Prior progression on or intolerance to treatment with a fluoropyrimidine and oxaliplatin. Recurrence of disease within 6 months from the completion of adjuvant therapy with both a fluoropyrimidine and oxaliplatin is considered progression.
- Patients must have measurable disease as per the revised Response Evaluation Criteria In Solid Tumors (RECIST) criteria (Version 1.1).
- If radiation was previously received, the measurable disease must be outside the previous radiation field, unless this area has demonstrated evidence of radiographic growth.
- A minimum of 2 weeks must have elapsed from completion of any prior chemotherapy or radiotherapy or surgery and the start date of study therapy.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 - 2.
- Adequate organ function including: a) Absolute neutrophil count (ANC) =/>1,000/ul; b) Platelets =/>75,000/ul; c) Total bilirubin =/< 1.5 x ULN; in patients with known Gilbert's syndrome direct bilirubin =/<1.5 x ULN will be used as organ function criteria, instead of total bilirubin; d) AST (SGOT)/ALT (SGPT) < 3 x ULN; e) Creatinine <2 x ULN.
- Negative urine or serum pregnancy test in women with childbearing potential (defined as not post-menopausal for 12 months or no previous surgical sterilization), within one week prior to initiation of treatment.
- The effects of panitumumab on the developing fetus are unknown. For this reason, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry, for the duration of study participation, and for six months following the completion of therapy. Should a woman become pregnant while participating in this study, she should inform her treating physician immediately.
- Patients must sign an Informed Consent and Authorization indicating that they are aware of the investigational nature of this study and the known risks involved.
- Magnesium level =/> lower limit of normal.
- Prior anti-epidermal growth factor receptor antibody therapy (eg. panitumumab or cetuximab) or prior small molecule anti-epidermal growth factor receptor therapy (eg. erlotinib) for adenocarcinoma of the small bowel or ampulla of Vater.
- Patients may not be receiving any other investigational agents nor have received any investigational drug 30 days prior to enrollment.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit adherence with study requirements.
- Interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung.
- Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with panitumumab, breast feeding must be discontinued.
- Age <18 years. Because no dosing or adverse event data are currently available on the use of panitumumab in patients <18 years of age, children are excluded from this study.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01202409
|Contact: Michael Overman, MD
|University of Texas MD Anderson Cancer Center
|Houston, Texas, United States, 77030 |
|Contact: Michael Overman, MD 713-745-4317 |
|Principal Investigator: Michael Overman, MD |
M.D. Anderson Cancer Center
||Michael Overman, MD
||M.D. Anderson Cancer Center
No publications provided
||M.D. Anderson Cancer Center
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 14, 2010
||July 15, 2015
||United States: Food and Drug Administration
Keywords provided by M.D. Anderson Cancer Center:
Ampulla of Vater
Adenocarcinoma of the small bowel
Kirsten rat sarcoma
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on August 27, 2015
Digestive System Diseases
Digestive System Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial