Clinical trial · Interventional

Study of Panitumumab Given First With Capecitabine and Oxaliplatin (CAPOX) and Then With Capecitabine and Radiation of the Pelvis for Treatment of Patients With Rectal Cancers That May or May Not Have Spread Beyond the Rectum

A Phase II Study to Determine the Efficacy and Safety of Panitumumab in Combination With Chemoradiotherapy for Unresectable or Locally Recurrent Adenocarcinoma of the Rectum With or Without Metastatic Disease

NCT00346099CI-TRIAL-00001086withdrawnPhase 2ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Why stopped (as posted): Protocol closed based on new (and as yet unpublished) information from a phase II clinical trial.

Summary

Brief summary (as posted)

Panitumumab is a monoclonal antibody. It works by attaching to a protein called epidermal growth factor receptor found on normal and cancer cells. When panitumumab attaches, it blocks another protein called epidermal growth factor (EGF) from attaching to the cell. This is important because, when EGF is blocked, a cell's growth slows down or stops. Panitumumab may also help radiation therapy work. Also because panitumumab is a fully-human antibody, it may be less toxic than other monoclonal antibodies made to block the EGF receptor. Chemotherapy, such as capecitabine and oxaliplatin, works to kill cancer cells directly. Capecitabine given during radiation helps radiation therapy work better. This study is being done to learn how rectal cancer tumors that are not removed surgically respond to treatment with panitumumab and chemotherapy given before radiation therapy begins followed by treatment with panitumumab and capecitabine given with radiation therapy.

Conditions

Conditions (2)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Neoplasm Metastasis	—	UNRESOLVED	—
Rectal Cancer	Malignant Rectal Neoplasm	CURATED_EXACT	0.92

Interventions

Interventions (2)

Intervention	Type	Mapped drug	Match
Panitumumab with capecitabine and oxaliplatin (CAPOX) followed by	Drug	—	UNRESOLVED
Panitumumab with capecitabine and radiation	Drug	—	UNRESOLVED

Design

Arms and outcomes

Arms (0)

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Primary outcomes (1)

measure
Percentage of patients with clinical complete response rate in tumor in the pelvis at 4 to 6 weeks after completion of radiation therapy

Secondary outcomes (4)

measure
Percentage of patients with pathologic complete response rate of the primary rectal tumor and resected regional lymph nodes(tissue removed at the time of surgery)
measure
Percentage of patients whose surgical evaluation following therapy indicates candidacy for resection
measure
Percentage of patients who have progressive disease in the pelvis from the time of study entry to 2 years
measure
The toxicity of panitumumab in combination with chemotherapy and in combination with chemoradiotherapy

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

Inclusion Criteria:

* Pathologic diagnosis of rectal cancer (adenocarcinoma)
* Must have rectal cancer that is:

  * locally advanced and considered not to be curable by surgery
  * recurrent (if it was treated before by surgical removal of the tumor)
  * present along with small-volume metastasis
* Evidence of adequate organ function (such as liver, kidneys, etc.)
* Must be able to swallow tablets
* Able to perform an adequate level of physical activity

Exclusion Criteria:

* Diagnosis of rectal cancer other than adenocarcinoma
* Patients who are candidates for surgical removal of metastatic and/or locally advanced disease
* Patients who have received previous treatments for the current cancer
* Chronic liver disease or recurrent viral hepatitis
* Any previous pelvic radiation therapy and/or any previous chemotherapy with oxaliplatin or epidermal growth factor receptor inhibitors
* Central nervous system metastases
* Active inflammatory bowel disease
* Current clinically significant abnormal peripheral nerve disease
* Active heart disease, including blocked blood vessels, recent heart attack, history of congestive heart failure, or abnormal heart beat
* Pregnancy or breast feeding

References

Publications (0)

Data not yet available

No reference posted for this study.