Clinical trial · Interventional
Oxaliplatin With or Without Gefitinib in Treating Patients With Metastatic or Locally Recurrent Colorectal Cancer
A Phase I/ Randomized Phase II Trial Of Oxaliplatin (NSC #266046) With Or Without ZD 1839 (NSC # 715055) In Patients With Advanced Colorectal Carcinoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Biological therapies such as gefitinib may interfere with the growth of the tumor cells and slow the growth of colorectal cancer. Combining chemotherapy with gefitinib may kill more tumor cells. PURPOSE: Phase I/II trial to compare the effectiveness of chemotherapy with or without gefitinib in treating patients who have metastatic or locally recurrent colorectal cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| oxaliplatin | Drug | Oxaliplatin | ALIAS |
| ZD1839 | Drug | Gefitinib | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Phase 2: Oxaliplatin plus ZD1839
- description
- Oxaliplatin will be administered by IV infusion once every 21 days at a fixed dose of 130 mg/m2 and ZD1839 will be taken orally at a dose of 250 mg or 500 mg daily (as determined during phase 1). Subjects can continue to receive the combination for 6 cycles (each cycle is 21 days). After 6 cycles of the combination, subjects can continue to take ZD1839 alone until their cancer worsens.
- interventionNames
- Drug: ZD1839
- Drug: oxaliplatin
- type
- EXPERIMENTAL
- label
- Phase 2: Oxaliplatin alone
- description
- Oxaliplatin will be administered by IV infusion once every 21 days at a fixed dose of 130 mg/m2 for up to 6 cycles. Each cycle will last 21 days.
- interventionNames
- Drug: oxaliplatin
- type
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed adenocarcinoma of the colon or rectum that is not amenable to potentially curative surgical resection * Metastatic or locally recurrent disease * Tumor in liver or lung accessible to needle biopsy by ultrasound or CT scan guidance * At least 1 measurable lesion * At least 20 mm by conventional techniques, including physical examination, CT scan, or MRI OR * At least 10 mm by spiral CT scan * Lesions on colonoscopic examination or barium studies, bone metastases, CNS lesions, and ascites are not considered measurable * Failed prior therapy with fluorouracil, leucovorin calcium, and irinotecan given either sequentially or in combination * No known brain metastases PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 Life expectancy: * At least 3 months Hematopoietic: * WBC at least 3,000/mm\^3 * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin no greater than 1.5 mg/dL * AST/ALT no greater than 2.5 times upper limit of normal Renal: * Creatinine no greater than 1.5 mg/dL OR * Creatinine clearance at least 60 mL/min Cardiovascular: * No symptomatic congestive heart failure * No unstable angina pectoris * No cardiac arrhythmia Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No peripheral neuropathy greater than grade 1 * No other concurrent uncontrolled illness that would preclude study * No concurrent psychiatric illness or social situation that would preclude study * No ongoing or active infection * No prior allergic reaction to compounds of similar chemical or biologic composition to oxaliplatin or gefitinib * No other concurrent malignancy except non-melanoma skin cancer or carcinoma in situ of the cervix unless considered to be at less than 30% risk of relapse after completion of therapy PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior epidermal growth factor inhibitor * At least 24 hours since prior colony-stimulating factors * No concurrent colony-stimulating factors during first course of study therapy Chemotherapy: * See Disease Characteristics * No more than 2 prior chemotherapy regimens for metastatic disease * Prior adjuvant chemotherapy allowed * At least 4 weeks since prior cytotoxic chemotherapy and recovered * No prior cisplatin or oxaliplatin Endocrine therapy: * Not specified Radiotherapy: * At least 4 weeks since prior radiotherapy and recovered Surgery: * See Disease Characteristics * At least 4 weeks since prior surgery Other: * At least 30 days since prior investigational agents * Recovered from prior therapy * No concurrent anti-retroviral therapy for HIV * No other concurrent investigational or commercial agents or therapies for malignancy
References
Publications (1)
- RESULTKindler HL, Friberg G, Skoog L, Wade-Oliver K, Vokes EE. Phase I/II trial of gefitinib and oxaliplatin in patients with advanced colorectal cancer. Am J Clin Oncol. 2005 Aug;28(4):340-4. doi: 10.1097/01.coc.0000159558.19631.d5. PMID 16062074